LKF

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

Advisory panel: Obstetrics/Gynecology
Total cleared: 87

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LKF

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.