FDA Product Code
FDA Product Code LKF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | 2025-11-26 | Traditional | PDF ↗ |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | 2024-10-16 | Traditional | PDF ↗ |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024-09-06 | Traditional | PDF ↗ |
| K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022-12-16 | Traditional | PDF ↗ |
| K223064 | ALLY II Uterine Positioning System (UPS) | CooperSurgical, Inc. | 2022-10-28 | Special | PDF ↗ |
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | 2022-03-31 | Traditional | PDF ↗ |
| K212505 | DUMI ManipulatOR | The O R Company Pty, Ltd. | 2022-01-10 | Traditional | PDF ↗ |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019-03-29 | Traditional | PDF ↗ |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018-10-26 | Traditional | PDF ↗ |
| K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018-10-26 | Traditional | PDF ↗ |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018-06-26 | Traditional | PDF ↗ |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated | 2018-02-15 | Traditional | PDF ↗ |
| K163214 | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | 2017-02-07 | Traditional | PDF ↗ |
| K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016-10-06 | Traditional | PDF ↗ |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015-12-21 | Special | PDF ↗ |
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | 2015-08-19 | Traditional | PDF ↗ |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015-02-26 | Traditional | PDF ↗ |
| K142716 | VCARE | Conmed Corporation | 2015-02-10 | Traditional | PDF ↗ |
| K142164 | MANIPULATOR; MANIPULATOR PRO | Gynetech Pty. , Ltd. | 2014-12-17 | Traditional | PDF ↗ |
| K141523 | ALLY UPS | CooperSurgical, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K131781 | CLEARVIEW TOTAL | Clinical Innovations, LLC | 2014-05-28 | Traditional | PDF ↗ |
| K130758 | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER | Kronner Prototypes, Inc. | 2013-12-11 | Traditional | PDF ↗ |
| K122820 | VIKY UP | Endocontrol | 2013-06-18 | Traditional | PDF ↗ |
| K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | Catheter Research, Inc. | 2013-01-31 | Special | PDF ↗ |
| K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE | Panpac Medical Corporation | 2011-12-15 | Traditional | PDF ↗ |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | Femasys, Inc. | 2011-10-12 | Traditional | PDF ↗ |
| K110288 | FEMVUE SALINE-AIR DEVICE | Femasys, Inc. | 2011-04-28 | Traditional | PDF ↗ |
| K092983 | PANPAC HSG CATHETER SET | Panpac Medical Corporation | 2010-06-07 | Traditional | PDF ↗ |
| K092969 | H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F | Sterling Medical, Inc. | 2010-04-30 | Traditional | PDF ↗ |
| K092984 | PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 | Panpac Medical Corporation | 2010-04-07 | Traditional | PDF ↗ |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | Femasys, Inc. | 2010-04-07 | Special | PDF ↗ |
| K093556 | VCARE DX | Conmed Corporation | 2010-03-12 | Traditional | PDF ↗ |
| K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | Panpac Medical Corporation | 2010-03-11 | Traditional | PDF ↗ |
| K083594 | EZ HSG CATHETER.FOAMSEAL CATHETER | Obg Products | 2009-07-21 | Traditional | PDF ↗ |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | Femasys, Inc. | 2009-06-23 | Traditional | PDF ↗ |
| K071405 | PROBE HOLDER SYSTEM | Intuitive Surgical, Inc. | 2007-10-09 | Traditional | PDF ↗ |
| K071907 | VCARE RETRACTOR/ELEVATOR | Conmed Corporation | 2007-10-05 | Special | PDF ↗ |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | Utah Medical Products, Inc. | 2007-05-23 | Traditional | PDF ↗ |
| K061679 | WALLACE ARTIFICIAL INSEMINATION CATHETER | Irvine Scientific Sales Co., Inc. | 2006-10-13 | Traditional | PDF ↗ |
| K041062 | INTRAUTERINE VENOGRAM NEEDLE SET | Cook Urological, Inc. | 2004-10-01 | Traditional | PDF ↗ |
| K040238 | SOFTSEAL HSG CATHETER | Modern Medical Equipment Mfg., Ltd. | 2004-06-22 | Traditional | PDF ↗ |
| K041094 | HSG CATHETER SET | Bioteque America, Inc. | 2004-06-17 | Traditional | PDF ↗ |
| K032835 | H/S CATHETER SET | Catheter Research, Inc. | 2003-12-11 | Traditional | PDF ↗ |
| K023051 | INTRAUTERINE DELIVERY SYSTEM - INJECTOR | Prosurg, Inc. | 2002-12-12 | Traditional | PDF ↗ |
| K022503 | UTERINE INJECTOR | Thomas Medical, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K021272 | SIB CATHETER, MODEL 61-7005 | Ackrad Laboratories | 2002-05-21 | Special | PDF ↗ |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Ackrad Laboratories | 2002-04-24 | Special | PDF ↗ |
| K020292 | UTERINE INJECTOR | Catheter Research, Inc. | 2002-04-17 | Traditional | PDF ↗ |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Ackrad Laboratories | 2002-04-16 | Special | PDF ↗ |
| K013972 | H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 | Ackard Laboratories | 2001-12-17 | Special | PDF ↗ |
| K013437 | SF SH CATHETER, MODEL R65-945 | A & A Medical, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K013491 | HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 | A & A Medical, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K010296 | UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 | Marina Medical Instruments, Inc. | 2001-04-11 | Traditional | PDF ↗ |
| K010056 | UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 | A & A Medical, Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K000433 | PBN HYSTERO-SALPINGOGRAPHY CATHETER SET | Medical Device Technologies, Inc. | 2000-06-16 | Traditional | PDF ↗ |
| K001115 | ULTRA CATHETER SET | Lyco Enterprises, Inc. | 2000-05-17 | Traditional | PDF ↗ |
| K974357 | UTERINE MANIPULATOR/INJECTOR | Catheter Research, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Ackrad Laboratories | 1997-04-09 | Traditional | PDF ↗ |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1996-08-08 | Traditional | PDF ↗ |
| K955446 | CONMED VCARE RETRACTOR/ELEVATOR | Conmedcorp | 1996-06-18 | Traditional | PDF ↗ |
| K955508 | ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET | Cook Urological, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K946220 | CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR | Conmedcorp | 1995-09-15 | Traditional | PDF ↗ |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | 1995-08-29 | Traditional | PDF ↗ |
| K943494 | HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY | Lyco Enterprises, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K931167 | OVAMED FALLOPIAN OSTIAL ACCESS CATHETER | Ovamed Corp. | 1995-06-22 | Traditional | PDF ↗ |
| K943448 | LUMIN | Utah Medical Products, Inc. | 1995-04-11 | Traditional | PDF ↗ |
| K931122 | OVAMED HSG CATHETER | Ovamed Corp. | 1995-01-30 | Traditional | PDF ↗ |
| K932394 | BERNSTEIN(TM) UTERINE MANIPULATOR | Gm Engineering, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Zinnanti Surgical Instruments, Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K941457 | UTERINE INJECTOR WITH SPRING | Zinnanti Surgical Instruments, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K935023 | GODAT UTERINE MANIPULATOR INJECTOR | Ideas For Medicine, Inc. | 1995-01-04 | Traditional | PDF ↗ |
| K933723 | CONCEPTUS UTERINE CATHETER | Conceptus, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K933981 | CERVICAL CATHETER | Conceptus, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K940681 | CLEARVIEW UTERINE MANIPULATOR | Clinical Innovations, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K930867 | AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 | Traditional | PDF ↗ |
| K932115 | ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI | Blairden Precision Instruments, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K931814 | DMI UTERINE MOBILIZER/ELEVATOR/CANNULA | Diversified Medical Instruments, Inc. | 1994-05-31 | Traditional | PDF ↗ |
| K935434 | OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT | United States Surgical, A Division of Tyco Healthc | 1994-05-27 | Traditional | PDF ↗ |
| K932432 | KRONNER REINFORCING STYLETTE | Unimar, Inc. | 1994-04-12 | Traditional | PDF ↗ |
| K930038 | CANNULA: KAHN, JARCO, CORSON AND RATCHET | Thomasville Medical Assoc. | 1994-02-18 | Traditional | PDF ↗ |
| K911887 | MAJOLI UTERINE MANIPULATOR/INJECTOR | Cook Ob/Gyn | 1991-07-26 | Traditional | PDF ↗ |
| K904079 | BARD UTERINE MANIPULATOR | C.R. Bard, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K902975 | TWIN BALLOON INJECTOR | Zinnanti Surgical Instruments, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K772230 | CANNULA, PERFUSION, FALLOPIAN TUBE | J. Sklar Mfg. Co., Inc. | 1978-01-03 | Traditional | PDF ↗ |
Product code LKF · Class II · Obstetrics/Gynecology. Data: openFDA.