Product Code: LKF FDA class 2 21 CFR 884.4530

Cannula, Manipulator/Injector, Uterine

Obstetrics/Gynecology

Cannula, Manipulator/Injector, Uterine is a surgical instrument used in gynecological procedures, particularly laparoscopy, to manipulate the uterus into various positions and to inject fluids into the uterine cavity. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKF, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LKF
Device Class: FDA class 2
Regulation Number: 884.4530
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 87 510(k) clearances via K numbers.

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