Cannula, Manipulator/Injector, Uterine

FDA product code LKF · 79 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4530
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-01-03 – 2025-12-15

LKF 2025-12-15

FemVue® Controlled Saline-Air Device (FSA-300)

Applicant Femasys, Inc.

K number K253403

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LKF 2025-11-26

RELIEEV HSG Catheter (HSG7FA1)

Applicant Li Medical Corporation , Ltd.

K number K252260

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LKF 2024-11-22

FemVue MINI Saline-Air Device

Applicant Femasys, Inc.

K number K242002

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LKF 2024-10-16

RELIEEV Uterine Manipulator Injector (CUMI 5.0)

Applicant Li Medical Corporation , Ltd.

K number K240364

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LKF 2024-09-06

FemChec Controlled Saline-Air Device (FCD-250)

Applicant Femasys, Inc.

K number K241693

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LKF 2022-12-16

Rejoni Intrauterine Catheter

Applicant Rejoni, Inc.

K number K222798

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LKF 2022-10-28

ALLY II Uterine Positioning System™ (UPS)

Applicant CooperSurgical, Inc.

K number K223064

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LKF 2022-03-31

Uterine ElevatOR PRO with OccludOR Balloon

Applicant The O R Company Pty, Ltd.

K number K220202

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LKF 2022-01-10

DUMI ManipulatOR

Applicant The O R Company Pty, Ltd.

K number K212505

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LKF 2019-03-29

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

Applicant Cook Incorporated

K number K181770

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LKF 2018-10-26

Margolin HSG Cannula, Goldstein Sonohysterography Catheter

Applicant Cook Incorporated

K number K180300

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LKF 2018-10-26

Cook Silicone Balloon HSG Catheter

Applicant Cook Incorporated

K number K180291

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LKF 2018-06-26

Uterine Manipulator

Applicant Beijing Hangtian Kadi Technology R&D Institute

K number K172846

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LKF 2018-02-15

Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip

Applicant Cook Incorporated

K number K171604

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LKF 2017-02-07

Unicare System, Unicare Manipulator

Applicant Clearpath Surgical, Inc.

K number K163214

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LKF 2016-10-06

uVue HSG/SHG Catheter

Applicant Cook Incorporated

K number K160217

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LKF 2013-12-11

KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER

Applicant Kronner Prototypes, Inc.

K number K130758

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LKF 2013-06-18

VIKY UP

Applicant Endocontrol

K number K122820

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LKF 2013-01-31

THE ADVANCE CATHETER FOR HSG AND SIS

Applicant Catheter Research, Inc.

K number K123258

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LKF 2011-12-15

BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE

Applicant Panpac Medical Corporation

K number K102898

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LKF 2011-10-12

FEMCHEC PRESSURE MANAGEMET DEVICE

Applicant Femasys, Inc.

K number K110993

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LKF 2011-04-28

FEMVUE SALINE-AIR DEVICE

Applicant Femasys, Inc.

K number K110288

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LKF 2010-06-07

PANPAC HSG CATHETER SET

Applicant Panpac Medical Corporation

K number K092983

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LKF 2010-04-30

H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F

Applicant Sterling Medical, Inc.

K number K092969

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LKF 2010-04-07

FEMVUE CORNUAL BALLOON CATHETER

Applicant Femasys, Inc.

K number K100662

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LKF 2010-04-07

PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0

Applicant Panpac Medical Corporation

K number K092984

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LKF 2010-03-12

VCARE DX

Applicant Conmed Corporation

K number K093556

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LKF 2010-03-11

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5

Applicant Panpac Medical Corporation

K number K092980

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LKF 2009-07-21

EZ HSG CATHETER.FOAMSEAL CATHETER

Applicant Obg Products

K number K083594

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LKF 2009-06-23

FEMVUE(TM) CATHETER SYSTEM

Applicant Femasys, Inc.

K number K083690

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LKF 2007-10-09

PROBE HOLDER SYSTEM

Applicant Intuitive Surgical, Inc.

K number K071405

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LKF 2007-10-05

VCARE RETRACTOR/ELEVATOR

Applicant Conmed Corporation

K number K071907

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LKF 2007-05-23

SALINE/ CONTRAST MEDIA INFUSION CATHETER

Applicant Utah Medical Products, Inc.

K number K063611

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LKF 2006-10-13

WALLACE ARTIFICIAL INSEMINATION CATHETER

Applicant Irvine Scientific Sales Co., Inc.

K number K061679

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LKF 2004-10-01

INTRAUTERINE VENOGRAM NEEDLE SET

Applicant Cook Urological, Inc.

K number K041062

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LKF 2004-06-22

SOFTSEAL HSG CATHETER

Applicant Modern Medical Equipment Mfg., Ltd.

K number K040238

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LKF 2004-06-17

HSG CATHETER SET

Applicant Bioteque America, Inc.

K number K041094

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LKF 2003-12-11

H/S CATHETER SET

Applicant Catheter Research, Inc.

K number K032835

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LKF 2002-12-12

INTRAUTERINE DELIVERY SYSTEM - INJECTOR

Applicant Prosurg, Inc.

K number K023051

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LKF 2002-10-25

UTERINE INJECTOR

Applicant Thomas Medical, Inc.

K number K022503

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LKF 2002-05-21

SIB CATHETER, MODEL 61-7005

Applicant Ackrad Laboratories

K number K021272

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LKF 2002-04-24

H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY

Applicant Ackrad Laboratories

K number K020954

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LKF 2002-04-17

UTERINE INJECTOR

Applicant Catheter Research, Inc.

K number K020292

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LKF 2002-04-16

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007

Applicant Ackrad Laboratories

K number K020951

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LKF 2001-12-17

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

Applicant Ackard Laboratories

K number K013972

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LKF 2001-11-19

HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948

Applicant A & A Medical, Inc.

K number K013491

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LKF 2001-11-19

SF SH CATHETER, MODEL R65-945

Applicant A & A Medical, Inc.

K number K013437

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LKF 2001-04-11

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

Applicant Marina Medical Instruments, Inc.

K number K010296

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LKF 2001-02-01

UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

Applicant A & A Medical, Inc.

K number K010056

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LKF 2000-06-16

PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

Applicant Medical Device Technologies, Inc.

K number K000433

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LKF 2000-05-17

ULTRA CATHETER SET

Applicant Lyco Enterprises, Inc.

K number K001115

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LKF 1998-02-02

UTERINE MANIPULATOR/INJECTOR

Applicant Catheter Research, Inc.

K number K974357

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LKF 1997-04-09

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER

Applicant Ackrad Laboratories

K number K970492

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LKF 1996-08-08

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

Applicant Ackrad Laboratories

K number K961752

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LKF 1996-06-18

CONMED VCARE RETRACTOR/ELEVATOR

Applicant Conmedcorp

K number K955446

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LKF 1996-02-26

ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET

Applicant Cook Urological, Inc.

K number K955508

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LKF 1995-09-15

CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR

Applicant Conmedcorp

K number K946220

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LKF 1995-08-29

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

Applicant Ackrad Laboratories

K number K953034

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LKF 1995-07-06

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY

Applicant Lyco Enterprises, Inc.

K number K943494

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LKF 1995-06-22

OVAMED FALLOPIAN OSTIAL ACCESS CATHETER

Applicant Ovamed Corp.

K number K931167

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LKF 1995-04-11

LUMIN

Applicant Utah Medical Products, Inc.

K number K943448

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LKF 1995-01-30

OVAMED HSG CATHETER

Applicant Ovamed Corp.

K number K931122

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LKF 1995-01-26

BERNSTEIN(TM) UTERINE MANIPULATOR

Applicant Gm Engineering, Inc.

K number K932394

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LKF 1995-01-25

UTERINE MANIPULATOR/INJECTOR WITH SPRING

Applicant Zinnanti Surgical Instruments, Inc.

K number K941458

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LKF 1995-01-24

UTERINE INJECTOR WITH SPRING

Applicant Zinnanti Surgical Instruments, Inc.

K number K941457

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LKF 1995-01-04

GODAT UTERINE MANIPULATOR INJECTOR

Applicant Ideas For Medicine, Inc.

K number K935023

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LKF 1994-12-27

CERVICAL CATHETER

Applicant Conceptus, Inc.

K number K933981

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LKF 1994-12-27

CONCEPTUS UTERINE CATHETER

Applicant Conceptus, Inc.

K number K933723

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LKF 1994-07-26

CLEARVIEW UTERINE MANIPULATOR

Applicant Clinical Innovations, Inc.

K number K940681

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LKF 1994-07-25

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR

Applicant United States Surgical, A Division of Tyco Healthc

K number K930867

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LKF 1994-06-24

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI

Applicant Blairden Precision Instruments, Inc.

K number K932115

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LKF 1994-05-31

DMI UTERINE MOBILIZER/ELEVATOR/CANNULA

Applicant Diversified Medical Instruments, Inc.

K number K931814

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LKF 1994-05-27

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT

Applicant United States Surgical, A Division of Tyco Healthc

K number K935434

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LKF 1994-04-12

KRONNER REINFORCING STYLETTE

Applicant Unimar, Inc.

K number K932432

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LKF 1994-02-18

CANNULA: KAHN, JARCO, CORSON AND RATCHET

Applicant Thomasville Medical Assoc.

K number K930038

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LKF 1991-07-26

MAJOLI UTERINE MANIPULATOR/INJECTOR

Applicant Cook Ob/Gyn

K number K911887

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LKF 1991-02-07

BARD UTERINE MANIPULATOR

Applicant C.R. Bard, Inc.

K number K904079

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LKF 1990-09-26

TWIN BALLOON INJECTOR

Applicant Zinnanti Surgical Instruments, Inc.

K number K902975

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LKF 1978-01-03

CANNULA, PERFUSION, FALLOPIAN TUBE

Applicant J. Sklar Mfg. Co., Inc.

K number K772230

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