ClearanceBrief
Panels › Obstetrics/Gynecology › Product code LKF · Class 2

Cannula, Manipulator/Injector, Uterine

Regulation 884.4530

2510(k)s in 12 months (87 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
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Top companies in LKF

Company510(k)sRecalls
CooperSurgical, Inc.46
Femasys, Inc.70
Ackrad Laboratories60
Catheter Research, Inc.41
Clinical Innovations, Inc.23
Cook Incorporated50
Panpac Medical Corporation40
A & A Medical, Inc.30
Conmed Corporation30
Zinnanti Surgical Instruments, Inc.30
Decided510(k)Device and applicantCode
Dec 15, 2025K253403FemVue® Controlled Saline-Air Device (FSA-300)
Femasys, Inc.
LKF
Nov 26, 2025K252260RELIEEV HSG Catheter (HSG7FA1)
Li Medical Corporation , Ltd., TW
LKF
Nov 22, 2024K242002FemVue MINI Saline-Air Device
Femasys, Inc.
LKF
Oct 16, 2024K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)
Li Medical Corporation , Ltd., TW
LKF
Sep 6, 2024K241693FemChec Controlled Saline-Air Device (FCD-250)
Femasys, Inc.
LKF
Dec 16, 2022K222798Rejoni Intrauterine Catheter
Rejoni, Inc.
LKF
Oct 28, 2022K223064ALLY II Uterine Positioning System™ (UPS)
CooperSurgical, Inc.
LKF
Mar 31, 2022K220202Uterine ElevatOR PRO with OccludOR Balloon
The O R Company Pty, Ltd., AU
LKF
Jan 10, 2022K212505DUMI ManipulatOR
The O R Company Pty, Ltd., AU
LKF
Mar 29, 2019K181770Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
Cook Incorporated
LKF
Oct 26, 2018K180300Margolin HSG Cannula, Goldstein Sonohysterography Catheter
Cook Incorporated
LKF
Oct 26, 2018K180291Cook Silicone Balloon HSG Catheter
Cook Incorporated
LKF
Jun 26, 2018K172846Uterine Manipulator
Beijing Hangtian Kadi Technology R&D Institute, CN
LKF
Feb 15, 2018K171604Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterizatio
Cook Incorporated
LKF
Feb 7, 2017K163214Unicare System, Unicare Manipulator
Clearpath Surgical, Inc.
LKF
Oct 6, 2016K160217uVue HSG/SHG Catheter
Cook Incorporated
LKF
Dec 21, 2015K153092Ally Uterine Positioning System
CooperSurgical, Inc.
LKF
Aug 19, 2015K150519ManipulatOR PRO, ManipulatOR
Gynetech Pty. , Ltd., AU
LKF
Mar 20, 2015K142545SonoFlow Sonohysterography and Sonohysterosalpingography Device
Crossbay Medical, Inc.
LKF
Feb 26, 2015K143415Air Bubble Based Infuser (ABBI)
CooperSurgical, Inc.
LKF
Feb 10, 2015K142716VCARE
Conmed Corporation
LKF
Dec 17, 2014K142164MANIPULATOR; MANIPULATOR PRO
Gynetech Pty. , Ltd.
LKF
Nov 25, 2014K141523ALLY UPS
CooperSurgical, Inc.
LKF
May 28, 2014K131781CLEARVIEW TOTAL
Clinical Innovations, LLC
LKF
Dec 11, 2013K130758KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
Kronner Prototypes, Inc.
LKF
Jun 18, 2013K122820VIKY UP
Endocontrol, FR
LKF
Jan 31, 2013K123258THE ADVANCE CATHETER FOR HSG AND SIS
Catheter Research, Inc.
LKF
Dec 15, 2011K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
Panpac Medical Corporation, TW
LKF
Oct 12, 2011K110993FEMCHEC PRESSURE MANAGEMET DEVICE
Femasys, Inc.
LKF
Apr 28, 2011K110288FEMVUE SALINE-AIR DEVICE
Femasys, Inc.
LKF
Jun 7, 2010K092983PANPAC HSG CATHETER SET
Panpac Medical Corporation, TW
LKF
Apr 30, 2010K092969H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
Sterling Medical, Inc.
LKF
Apr 7, 2010K100662FEMVUE CORNUAL BALLOON CATHETER
Femasys, Inc.
LKF
Apr 7, 2010K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
Panpac Medical Corporation, TW
LKF
Mar 12, 2010K093556VCARE DX
Conmed Corporation
LKF
Mar 11, 2010K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
Panpac Medical Corporation, TW
LKF
Jul 21, 2009K083594EZ HSG CATHETER.FOAMSEAL CATHETER
Obg Products
LKF
Jun 23, 2009K083690FEMVUE(TM) CATHETER SYSTEM
Femasys, Inc.
LKF
Oct 9, 2007K071405PROBE HOLDER SYSTEM
Intuitive Surgical, Inc.
LKF
Oct 5, 2007K071907VCARE RETRACTOR/ELEVATOR
Conmed Corporation
LKF
May 23, 2007K063611SALINE/ CONTRAST MEDIA INFUSION CATHETER
Utah Medical Products, Inc.
LKF
Oct 13, 2006K061679WALLACE ARTIFICIAL INSEMINATION CATHETER
Irvine Scientific Sales Co., Inc.
LKF
Oct 1, 2004K041062INTRAUTERINE VENOGRAM NEEDLE SET
Cook Urological, Inc.
LKF
Jun 22, 2004K040238SOFTSEAL HSG CATHETER
Modern Medical Equipment Mfg., Ltd.
LKF
Jun 17, 2004K041094HSG CATHETER SET
Bioteque America, Inc.
LKF
Dec 11, 2003K032835H/S CATHETER SET
Catheter Research, Inc.
LKF
Dec 12, 2002K023051INTRAUTERINE DELIVERY SYSTEM - INJECTOR
Prosurg, Inc.
LKF
Oct 25, 2002K022503UTERINE INJECTOR
Thomas Medical, Inc.
LKF
May 21, 2002K021272SIB CATHETER, MODEL 61-7005
Ackrad Laboratories
LKF
Apr 24, 2002K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
Ackrad Laboratories
LKF

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