FDA 510(k) Applications for Medical Device Product Code "LKF"
(Cannula, Manipulator/Injector, Uterine)

FDA 510(k) Number Applicant Device Name Decision Date
K013491 A & A MEDICAL, INC. HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 11/19/2001
K013437 A & A MEDICAL, INC. SF SH CATHETER, MODEL R65-945 11/19/2001
K010056 A & A MEDICAL, INC. UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 02/01/2001
K013972 ACKARD LABORATORIES H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 12/17/2001
K020951 ACKRAD LABORATORIES H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 04/16/2002
K953034 ACKRAD LABORATORIES H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) 08/29/1995
K961752 ACKRAD LABORATORIES H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) 08/08/1996
K020954 ACKRAD LABORATORIES H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY 04/24/2002
K970492 ACKRAD LABORATORIES INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER 04/09/1997
K021272 ACKRAD LABORATORIES SIB CATHETER, MODEL 61-7005 05/21/2002
K172846 Beijing HangTian KaDi Technology R&D Institute Uterine Manipulator 06/26/2018
K041094 BIOTEQUE AMERICA, INC. HSG CATHETER SET 06/17/2004
K932115 BLAIRDEN PRECISION INSTRUMENTS, INC. ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI 06/24/1994
K904079 C.R. BARD, INC. BARD UTERINE MANIPULATOR 02/07/1991
K032835 CATHETER RESEARCH, INC. H/S CATHETER SET 12/11/2003
K123258 CATHETER RESEARCH, INC. THE ADVANCE CATHETER FOR HSG AND SIS 01/31/2013
K020292 CATHETER RESEARCH, INC. UTERINE INJECTOR 04/17/2002
K974357 CATHETER RESEARCH, INC. UTERINE MANIPULATOR/INJECTOR 02/02/1998
K163214 ClearPath Surgical, Inc. Unicare System, Unicare Manipulator 02/07/2017
K940681 CLINICAL INNOVATIONS, INC. CLEARVIEW UTERINE MANIPULATOR 07/26/1994
K131781 CLINICAL INNOVATIONS, LLC CLEARVIEW TOTAL 05/28/2014
K933981 CONCEPTUS, INC. CERVICAL CATHETER 12/27/1994
K933723 CONCEPTUS, INC. CONCEPTUS UTERINE CATHETER 12/27/1994
K946220 CONMED CORP. CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR 09/15/1995
K955446 CONMED CORP. CONMED VCARE RETRACTOR/ELEVATOR 06/18/1996
K142716 CONMED CORPORATION VCARE 02/10/2015
K093556 CONMED CORPORATION VCARE DX 03/12/2010
K071907 CONMED CORPORATION VCARE RETRACTOR/ELEVATOR 10/05/2007
K171604 Cook Incorporated R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip 02/15/2018
K160217 COOK INCORPORATED uVue HSG/SHG Catheter 10/06/2016
K911887 COOK OB/GYN MAJOLI UTERINE MANIPULATOR/INJECTOR 07/26/1991
K041062 COOK UROLOGICAL, INC. INTRAUTERINE VENOGRAM NEEDLE SET 10/01/2004
K955508 COOK UROLOGICAL, INC. ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET 02/26/1996
K141523 COOPER SURGICAL, INC. ALLY UPS 11/25/2014
K143415 CooperSurgical, Inc Air Bubble Based Infuser (ABBI) 02/26/2015
K153092 CooperSurgical, Inc. Ally Uterine Positioning System 12/21/2015
K142545 CrossBay Medical, Inc. SonoFlow Sonohysterography and Sonohysterosalpingography Device 03/20/2015
K931814 DIVERSIFIED MEDICAL INSTRUMENTS, INC. DMI UTERINE MOBILIZER/ELEVATOR/CANNULA 05/31/1994
K122820 ENDOCONTROL VIKY UP 06/18/2013
K110993 FEMASYS INC. FEMCHEC PRESSURE MANAGEMET DEVICE 10/12/2011
K100662 FEMASYS INC. FEMVUE CORNUAL BALLOON CATHETER 04/07/2010
K110288 FEMASYS INC. FEMVUE SALINE-AIR DEVICE 04/28/2011
K083690 FEMASYS INC. FEMVUE(TM) CATHETER SYSTEM 06/23/2009
K932394 GM ENGINEERING, INC. BERNSTEIN(TM) UTERINE MANIPULATOR 01/26/1995
K150519 GYNETECH PTY. LTD. ManipulatOR PRO, ManipulatOR 08/19/2015
K142164 GYNETECH PTY. LTD. MANIPULATOR; MANIPULATOR PRO 12/17/2014
K935023 IDEAS FOR MEDICINE, INC. GODAT UTERINE MANIPULATOR INJECTOR 01/04/1995
K071405 INTUITIVE SURGICAL, INC. PROBE HOLDER SYSTEM 10/09/2007
K061679 IRVINE SCIENTIFIC SALES CO., INC. WALLACE ARTIFICIAL INSEMINATION CATHETER 10/13/2006
K772230 J. SKLAR MFG. CO., INC. CANNULA, PERFUSION, FALLOPIAN TUBE 01/03/1978
K130758 KRONNER PROTOTYPES, INC. KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER 12/11/2013
K943494 LYCO ENTERPRISES, INC. HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY 07/06/1995
K001115 LYCO ENTERPRISES, INC. ULTRA CATHETER SET 05/17/2000
K010296 MARINA MEDICAL INSTRUMENTS, INC. UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 04/11/2001
K000433 MEDICAL DEVICE TECHNOLOGIES, INC. PBN HYSTERO-SALPINGOGRAPHY CATHETER SET 06/16/2000
K040238 MODERN MEDICAL EQUIPMENT MFG., LTD. SOFTSEAL HSG CATHETER 06/22/2004
K083594 OBG PRODUCTS EZ HSG CATHETER.FOAMSEAL CATHETER 07/21/2009
K931167 OVAMED CORP. OVAMED FALLOPIAN OSTIAL ACCESS CATHETER 06/22/1995
K931122 OVAMED CORP. OVAMED HSG CATHETER 01/30/1995
K102898 Panpac Medical Corporation BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE 12/15/2011
K092983 Panpac Medical Corporation PANPAC HSG CATHETER SET 06/07/2010
K092984 Panpac Medical Corporation PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 04/07/2010
K092980 Panpac Medical Corporation PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 03/11/2010
K023051 PROSURG, INC. INTRAUTERINE DELIVERY SYSTEM - INJECTOR 12/12/2002
K092969 STERLING MEDICAL INC H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F 04/30/2010
K022503 THOMAS MEDICAL, INC. UTERINE INJECTOR 10/25/2002
K930038 THOMASVILLE MEDICAL ASSOC. CANNULA: KAHN, JARCO, CORSON AND RATCHET 02/18/1994
K932432 UNIMAR, INC. KRONNER REINFORCING STYLETTE 04/12/1994
K930867 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR 07/25/1994
K935434 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT 05/27/1994
K943448 UTAH MEDICAL PRODUCTS, INC. LUMIN 04/11/1995
K063611 UTAH MEDICAL PRODUCTS, INC. SALINE/ CONTRAST MEDIA INFUSION CATHETER 05/23/2007
K902975 ZINNANTI SURGICAL INSTRUMENTS, INC. TWIN BALLOON INJECTOR 09/26/1990
K941457 ZINNANTI SURGICAL INSTRUMENTS, INC. UTERINE INJECTOR WITH SPRING 01/24/1995
K941458 ZINNANTI SURGICAL INSTRUMENTS, INC. UTERINE MANIPULATOR/INJECTOR WITH SPRING 01/25/1995


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