FDA 510(k) Applications for Medical Device Product Code "ERL"
(Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)

FDA 510(k) Number Applicant Device Name Decision Date
K940016 ALAMO CITY DENTAL SUPPLY CO. ELECTRIC SURGICAL DRILL 11/22/1994
K833875 APPLIED RESEARCH CORP. SHEA FOOTPLATE MICRODRILL 06/22/1984
K833874 APPLIED RESEARCH CORP. SHEA MIDDLE EAR MICRODRILL 06/22/1984
K083720 BIEN-AIR SURGERY SA OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K 03/20/2009
K143492 Bien-Air Surgery SA OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece 03/04/2015
K841813 BOFORS NOBELPHARMA, INC. TISSUE INTEGRATED PROSTHESIS DRILL 08/10/1984
K831946 ENTRONICS SURGICAL DRILL-ELECTRIC-HANDPIECE 11/03/1983
K161376 Grace Medical, Inc. DragonFly Surgical Drill System 08/25/2016
K152744 GYRUS ACMI, INC DIEGO ELITE DRILL 06/10/2016
K121678 GYRUS ACMI, INC. DTAD 08/30/2012
K020594 GYRUS ENT L.L.C. DIEGO POWERED DISSECTOR AND DRILL SYSTEM 03/08/2002
K034004 GYRUS ENT L.L.C. DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE 03/03/2004
K973286 GYRUS ENT L.L.C. ENT IRRIGATING PUMP (70327700) 09/29/1997
K992994 GYRUS ENT L.L.C. TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; 11/23/1999
K792159 JEDMED INSTRUMENT CO. FISCH DRILL SYSTEM 11/27/1979
K150969 KARL STORZ ENDOSCOPY AMERICA, INC. Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces 01/08/2016
K950964 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ INTRA-HANDPIECES AND ACCESSORIES 03/24/1995
K053262 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES 12/19/2005
K003994 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES 04/13/2001
K822008 KELLEHER CORP. TORX OR TYPE MICRO MOTOR HANDPIECE 08/12/1982
K163247 LAURIMED LLC 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider 03/09/2017
K133133 LAURIMED LLC LAURIMED POLYPVAC MICRODEBRIDER 12/23/2013
K161101 LAURIMED LLC PolypVac Microdebrider (3.3mm and 4.0mm) 06/22/2016
K944476 LINVATEC CORP. APEX UNIVERSAL DRIVE SYSTEM 11/18/1994
K964548 LINVATEC CORP. APEX UNIVERSAL DRIVE SYSTEM 01/17/1997
K981637 LINVATEC CORP. INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY 07/20/1998
K951263 LINVATEC CORP. INTRAARC DRIVE SYSTEM 04/17/1995
K961192 LINVATEC CORP. IRRIGATION SYSTEM 04/26/1996
K974174 MEDNET LOCATOR, INC. ULTRABUR 03/10/1998
K943108 MEDNEXT, INC. MEDNEXT MICRO-DRILL 08/17/1994
K972057 MEDTREK CORP. POWERTREK INSTRUMENTS 11/05/1997
K963246 MEDTRONIC XOMED TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT 09/23/1996
K002224 MEDTRONIC XOMED XPS 3000 SYSTEM 12/04/2000
K011321 MEDTRONIC XOMED, INC. MODIFICATION TO XPS 3000 SYSTEM 06/26/2001
K041413 MEDTRONIC XOMED, INC. XPS 3000 SYSTEM 07/12/2004
K041523 MEDTRONIC XOMED, INC. XPS 3000 SYSTEM 07/23/2004
K073255 MEDTRONIC XOMED, INC. XPS 3000 SYSTEM 03/24/2008
K081277 MEDTRONIC XOMED, INC. XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) 09/05/2008
K150728 MEDTRONIC XOMED, INC. XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole 08/14/2015
K914346 MICRO SURGICAL INSTRUMENTS CORP. DRILL MODULES MODELS 2116/2117 11/27/1991
K854331 MICRO-AIRE SURGICAL INSTRUMENTS, INC. MICRO-AIRE OTO/NEURO DRILL SYSTEM 01/21/1986
K854332 MICRO-AIRE SURGICAL INSTRUMENTS, INC. MICRO-AIRE STAPES DRILL SYSTEM 01/21/1986
K945438 MICROMED DEVELOPMENT CORP. EDI-BUR MICRODRILL SYSTEMS 11/22/1994
K970965 MIDAS REX PNEUMATIC TOOLS, INC. MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) 04/09/1997
K962163 MISTEN MEDICAL CORP. MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL 07/25/1996
K021098 MRI DEVICES DAUM GMBH DAUM-LECTRIC MRI DRILLING MACHINE 12/03/2002
K021811 MTP MEDICAL TECHNICAL PROMOTION GMBH UNIDRIVE II PLUS DISPOSABLE TUBING SET 06/19/2002
K080722 NAKANISHI, INC. PRIMADO SURGICAL DRILL 09/17/2008
K972865 PROMEX, INC. PROMEX ENT TISSUE REMOVAL SYSTEM 09/29/1997
K954989 SMITH & NEPHEW DYONICS, INC. DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES 11/27/1995
K012456 SODEM SYSTEMS SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) 09/21/2001
K023070 SODEM SYSTEMS SODEM HIGH SPEED SYSTEM (PNEUMATIC) 01/28/2003
K802463 SPIRE MEDICAL, INC. MICRO-SURGICAL POWER INSTRUMENT SYSTEM 10/31/1980
K081814 STERILMED, INC. REPROCESSED ENT SHAVERS 12/17/2008
K080052 STRYKER CORP. STRYKER ESSX WITH NAVIGATION MOUNT 10/02/2008
K940710 STRYKER CORP. STRYKER MICRODEBRIDER SYSTEM 05/16/1994
K943569 STRYKER CORP. STRYKER TOTAL PERFORMANCE SYSTEM 01/09/1995
K152641 STRYKER CORPORATION Pi Drive Plus Motor, Extender 11/20/2015
K171840 Stryker Corporation Stryker Consolidated Operating Room Equipment (CORE) 2 Console 09/15/2017
K141935 STRYKER CORPORATION STRYKER S2 DRILL 09/26/2014
K112593 STRYKER CORPORATION STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM 05/01/2012
K990038 Stryker Endoscopy HUMMER TRAK SYSTEM 02/19/1999
K952681 STRYKER ENDOSCOPY STRYKER HUMMER II MICRODEBRIDER SYSTEM 07/20/1995
K972584 Stryker Endoscopy STRYKER HUMMER II MICRODEBRIDER SYSTEM 10/01/1997
K011381 STRYKER INSTRUMENTS HUMMER IV MICRODEBRIDER SYSTEM 05/25/2001
K040300 STRYKER INSTRUMENTS STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) 03/03/2004
K073633 STRYKER IRELAND LTD., INSTRUMENTS DIVISION STRYKER ESSX MICRODEBRIDER SYSTEM 08/26/2008
K983050 SURGICAL LASER TECHNOLOGIES, INC. PNEUMATIC CUTTER SYSTEM 11/25/1998
K981041 SURGICAL LASER TECHNOLOGIES, INC. SLT BIPOLAR SHEATH 08/27/1998
K965080 THE ANSPACH EFFORT, INC. ANSPACH MICROMAX SYSTEM 01/10/1997
K131053 THE ANSPACH EFFORT, INC. ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM 12/31/2013
K180063 The Anspach Effort, Inc. OCM-G1 Attachment 03/27/2018
K862807 TREACE MEDICAL, INC. TREACE DRILL SYSTEM 08/15/1986
K873154 TREACE MEDICAL, INC. TREACE MAGNUM OTO-TOOL SYSTEM 09/04/1987
K954796 TREBAY MEDICAL CORP. MICRO-INGRESSOR HANDIPIECE 11/06/1995
K954715 TREBAY MEDICAL CORP. MICRO-PLANER HANDPIECE 10/27/1995
K791407 XOMED, INC. WOMED NICRO-CRAFT POWER SYSTEM 08/22/1979
K781418 XOMED, INC. XOMED TRANSSPHENOIDAL HANDPIECE 08/31/1978
K983224 XOMED, INC. XPS DRILL SYSTEM 10/21/1998
K002828 XOMED, INC. XPS NITRO SYSTEM 10/17/2000
K972453 XOMED, INC. XPS STRAIGHTSHOT MICRORESECTOR 09/05/1997
K945659 XOMED-TREACE, INC. BLACKSTAR(TM) STAR SYSTEM 01/09/1995
K905800 XOMED-TREACE, INC. X-T AIR DRILL 04/22/1991


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