FDA 510(k) Applications for Medical Device Product Code "LFL"
(Instrument, Ultrasonic Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K101561 AMERICAN OPTISURGICAL, INC. TX1 TISSUE REMOVAL SYSTEM 08/27/2010
K031523 AOMORI OLYMPUS CO., LTD. OLYMPUS ULTRASONIC SURGICAL SYSTEM 10/01/2003
K031710 AOMORI OLYMPUS CO., LTD. OLYMPUS ULTRASONIC SURGICAL SYSTEM 08/29/2003
K042160 AOMORI OLYMPUS CO., LTD. SONOSURG TROCAR 01/25/2005
K041566 AOMORI OLYMPUS CO., LTD. SONOSURG ULTRASONIC SURGICAL SYSTEM 09/08/2004
K062544 AROBELLA MEDICAL, LLC AR1000 ULTRASONIC WOUND THERAPY SYSTEM 01/03/2007
K021929 AXYA MEDICAL, INC. AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM 09/10/2002
K964742 AZIZ Y. ANIS, M.D. RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM 04/22/1997
K980895 CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR 11/06/1998
K801623 CAVITRON CORP. CAVITRON ULTRASONIC SURG. ASPIR. CUSA 11/18/1980
K880166 CLINICAL TECHNOLOGY CORP. BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 02/18/1988
K864983 COOPER LASERSONICS, INC. CUSA SYSTEM 200 MACRO-DISSECTOR 06/23/1987
K851203 COOPERVISION, INC. R PAK 07/23/1985
K153371 COVIDIEN LLC Sonicision Cordless Ultrasonic Dissection Device 03/28/2016
K101797 COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T 02/24/2011
K141371 COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H SONICISION CORDLESS ULTRASONIC DISSECTOR 08/07/2014
K180149 Covidien, llc Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide 03/26/2018
K150271 ENDOPRIME, INC. Prime Adaptive Ultrasonic Scalpel System 05/29/2015
K160752 ETHICON ENDO-SUREGERY, LLC HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length 06/29/2016
K042777 ETHICON ENDO-SURGERY, INC. HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P 12/01/2004
K051036 ETHICON ENDO-SURGERY, INC. HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P 06/02/2005
K053056 ETHICON ENDO-SURGERY, INC. HARMONIC SCALPEL BLADES AND SHEARS 01/19/2006
K060245 ETHICON ENDO-SURGERY, INC. HARMONIC SCALPEL BLADES AND SHEARS 04/07/2006
K062000 ETHICON ENDO-SURGERY, INC. HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH 09/25/2006
K980099 ETHICON ENDO-SURGERY, INC. ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) 04/09/1998
K962584 ETHICON ENDO-SURGERY, INC. ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE 11/04/1996
K983316 ETHICON ENDO-SURGERY, INC. ULTRACISION 5MM INSTRUMENTS 10/21/1998
K971302 ETHICON ENDO-SURGERY, INC. ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE 07/07/1997
K012176 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 10/01/2001
K010898 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 05/31/2001
K993054 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 12/09/1999
K990430 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL HAND PIECE 03/12/1999
K994280 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 03/17/2000
K002906 ETHICON ENDO-SURGERY, INC. ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 12/15/2000
K072203 ETHICON ENDO-SURGERY, LLC HARMONIC 10CM COMBINATION HOOK BLADE 09/25/2007
K132522 ETHICON ENDO-SURGERY, LLC HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE 12/16/2013
K132512 ETHICON ENDO-SURGERY, LLC HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE 10/24/2013
K121550 ETHICON ENDO-SURGERY, LLC HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY 08/22/2012
K132612 ETHICON ENDO-SURGERY, LLC HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE 10/17/2013
K063192 ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP 01/30/2007
K151340 ETHICON ENDO-SURGERY, LLC HARMONIC Focus Long Shears + Adaptive Tissue Technology 07/10/2015
K100597 ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS SHEARS 04/07/2010
K133314 ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY 12/03/2013
K151136 ETHICON ENDO-SURGERY, LLC HARMONIC HOOK 03/04/2016
K120729 ETHICON ENDO-SURGERY, LLC HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 05/17/2012
K983199 FIBRA SONICS, INC. FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL 12/14/1998
K980930 FIBRA SONICS, INC. FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA 09/22/1998
K830753 HEWLETT-PACKARD CO. NEEDLE GUIDE MODEL 21285A 06/16/1983
K893926 HOLL MEDITRONICS, INC. "SONOCA" ULTRASONIC SURGICAL SYSTEM 11/14/1989
K901737 HOLL MEDITRONICS, INC. SONOCA II ULTRASONIC SURGICAL DEVICE 07/03/1990
K942095 HOLL MEDITRONICS, INC. SONOCA III 11/09/1994
K113570 INTEGRA BURLINGTON MA, INC. INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP 02/22/2012
K111741 INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI INTEGRA(TM) CUSA NXT(TM) BONE TIPS 08/23/2011
K150682 INTEGRA LIFESCIENCES CORP. CUSA Excel+ 12/18/2015
K161882 INTEGRA LIFESCIENCES CORPORATION CUSA Clarity Ultrasonic Surgical Aspirator System 10/14/2016
K141668 INTEGRA LIFESCIENCES CORPORATION CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM 11/06/2014
K141674 INTEGRA LIFESCIENCES CORPORATION CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM 11/06/2014
K172595 Integra LifeSciences Corporation CUSA Excel+ Ultrasonic Surgical Aspirator System 09/28/2017
K021989 INTEGRA NEUROSCIENCES SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 09/13/2002
K042277 INTEGRA NEUROSCIENCES, LTD. SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM 09/29/2004
K090864 INTEGRA RADIONICS, INC. CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM 05/08/2009
K102258 INTEGRA RADIONICS, INC. CUSA NXT EXTENDED LENGTH TIP 06/10/2011
K081459 INTEGRA RADIONICS, INC. CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM 08/13/2008
K071669 INTEGRA RADIONICS, INC. INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP 08/17/2007
K852539 JOHNSON & JOHNSON PROFESSIONALS, INC. SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP 07/23/1985
K070360 KIRWAN SURGICAL PRODUCTS, INC. KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 08/07/2007
K932094 MDT CORP., INC. BOVIE ULTRASONIC SURGICAL ASPIRATOR 07/21/1993
K821820 MEDICAL COMPONENTS, INC. MCSC6PS MEDICAL COMPONENTS 07/13/1982
K972148 MEDICAMAT S.A. B.U.S. ENDOTRON 12/10/1997
K933559 MEDSONIC, INC. ALLIGER ULTRASONIC SURGICAL SYSTEM 10/15/1993
K970471 MENTOR CORP. MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) 07/17/1997
K983065 MENTOR CORP. MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM 12/01/1998
K000927 MISONIX, INC. ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 10/10/2000
K012028 MISONIX, INC. ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 07/27/2001
K050776 MISONIX, INC. AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM 06/06/2005
K032690 MISONIX, INC. MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM 12/09/2003
K070313 MISONIX, INC. MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM 05/11/2007
K982841 MISONIX, INC. MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 09/04/1998
K062471 MISONIX, INC. ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF 10/26/2006
K962525 MORWEL CORP. ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM 09/19/1996
K010309 MUTOH AMERICA CO., LTD. SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR 04/18/2001
K880814 NIIC U.S.A., INC. DX101 ULTRASONIC SURGICAL SYSTEM 04/13/1988
K880815 NIIC U.S.A., INC. DX101-T ULTRASONIC SURGICAL SYSTEM 04/13/1988
K172691 OLYMPUS MEDICAL SYSTEMS CORP. Ultrasonic Generator 10/04/2017
K050885 OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG 06/03/2005
K031305 OLYMPUS OPTICAL CO., LTD. OLYMPUS ULTRASONIC SURGICAL SYSTEM 09/23/2003
K993628 OMNISONICS MEDICAL TECHNOLOGIES OMNISONICS ULTRASONIC PROBES 12/15/1999
K003824 OMNISONICS MEDICAL TECHNOLOGIES OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI 03/08/2001
K051947 RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE 08/22/2005
K971609 SERVIZI MEDICO ESTETICI ITALINAI SRL. SCULPTURE 08/14/1997
K883091 SHARPLAN LASERS, INC. SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS 10/14/1988
K960040 SHARPLAN LASERS, INC. SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE 04/29/1996
K072904 SOERING GMBH SONOCA 180/195 WOUND CARE SYSTEM 05/21/2008
K971533 SONICS & MATERIALS, INC. VIBRA-SURGE SYSTEM MODEL VS2120 07/25/1997
K990572 SONOKINETICS, INC. SONOTOME 05/21/1999
K012753 SORING GMBH MEDIZINTECHNIK SORING GMBH SONOCA 180/190 11/13/2001
K991791 SOUND SURGICAL TECHNOLOGIES LLC. SOUND VASER SYSTEM 08/12/1999
K993868 SOUND SURGICAL TECHNOLOGIES LLC. THE SOUNDVASER DISSECTION SYSTEM 12/21/1999
K901974 SPEMBLY MEDICAL LTD. SELECTOR ULTRASONIC SURGICAL ASPIRATOR 09/05/1990
K032424 SRA DEVELOPMENTS, LTD. LOTUS 12/16/2003
K151101 SRA DEVELOPMENTS, LTD. Lotus Series 4 Ultrasonic Surgical System & Accessories 07/17/2015
K063531 SRA DEVELOPMENTS, LTD. SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM 02/22/2007
K904010 SURGEON SURGICAL INSTRUMENTATION, INC. SURGICAL ASPIRATOR KIT 11/21/1990
K010637 SYNERGETICS, INC. SONOTOME ULTRASONIC ASPIRATOR TIPS 04/20/2001
K020220 SYNERGETICS, INC. ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE 08/23/2002
K123640 TENEX HEALTH TX1 TISSUE REMOVAL SYSTEM 03/20/2013
K153299 TENEX HEALTH, INC. Tenex Health TX System 03/03/2016
K181367 Tenex Health, Inc. Tenex Health TX System 08/28/2018
K972114 THE OLYMPUS OPTICAL CO. OLYMPUS SONOSURG SYSTEM 05/18/1998
K000095 THE OLYMPUS OPTICAL CO. OLYMPUS SONOSURG TROCAR XT3900 SYSTEM 09/26/2000
K021962 THE OLYMPUS OPTICAL CO. OLYMPUS ULTRASONIC SURGICAL SYSTEM 02/12/2003
K032066 THE OLYMPUS OPTICAL CO. SONOSURG SYSTEM 10/03/2003
K960374 ULTRALASE TECHNOLOGIES, INC. ULTRACUT 2000 06/28/1996
K971861 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC ULTRASONIC HAND INSTRUMENTS 07/01/1997
K950945 VALLEYLAB, INC. COOPER LASER SONICS CUSA MODEL 200 04/10/1995
K981262 VALLEYLAB, INC. CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM 07/06/1998
K921251 VALLEYLAB, INC. CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR 06/12/1992
K964601 VALLEYLAB, INC. CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY 01/16/1997
K894600 VALLEYLAB, INC. CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR 01/19/1990
K931902 VALLEYLAB, INC. CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. 09/16/1994
K934628 VALLEYLAB, INC. CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS 07/11/1995
K910696 VALLEYLAB, INC. CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR 06/11/1991
K933239 VALLEYLAB, INC. CV720-727-000, MICROTIP AND FLUE PAK 10/12/1993
K971580 WELLS JOHNSON CO. UAS ULTRASONIC ASPIRATOR SYSTEM 12/09/1997


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