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 |
| 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 |
| 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 |
| K131781 | CLINICAL INNOVATIONS, LLC | CLEARVIEW TOTAL | 05/28/2014 |
| 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 |
| K180291 | Cook Incorporated | Cook Silicone Balloon HSG Catheter | 10/26/2018 |
| K181770 | Cook Incorporated | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | 03/29/2019 |
| K180300 | Cook Incorporated | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | 10/26/2018 |
| 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 |
| 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 |
| K223064 | CooperSurgical, Inc. | ALLY II Uterine Positioning SystemÖ (UPS) | 10/28/2022 |
| K153092 | CooperSurgical, Inc. | Ally Uterine Positioning System | 12/21/2015 |
| K142545 | CrossBay Medical, Inc. | SonoFlow Sonohysterography and Sonohysterosalpingography Device | 03/20/2015 |
| 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 |
| K150519 | GYNETECH PTY. LTD. | ManipulatOR PRO, ManipulatOR | 08/19/2015 |
| K142164 | GYNETECH PTY. LTD. | MANIPULATOR; MANIPULATOR PRO | 12/17/2014 |
| K071405 | INTUITIVE SURGICAL, INC. | PROBE HOLDER SYSTEM | 10/09/2007 |
| K061679 | IRVINE SCIENTIFIC SALES CO., INC. | WALLACE ARTIFICIAL INSEMINATION CATHETER | 10/13/2006 |
| K130758 | KRONNER PROTOTYPES, INC. | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER | 12/11/2013 |
| 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 |
| 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 |
| K222798 | Rejoni, Inc. | Rejoni Intrauterine Catheter | 12/16/2022 |
| 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 |
| K212505 | The O R Company Pty Ltd | DUMI ManipulatOR | 01/10/2022 |
| K220202 | The O R Company Pty Ltd | Uterine ElevatOR PRO with OccludOR Balloon | 03/31/2022 |
| K022503 | THOMAS MEDICAL, INC. | UTERINE INJECTOR | 10/25/2002 |
| K063611 | UTAH MEDICAL PRODUCTS, INC. | SALINE/ CONTRAST MEDIA INFUSION CATHETER | 05/23/2007 |
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