Product Code: HCZ FDA class 2 21 CFR 884.4530

Forceps, Surgical, Gynecological

Obstetrics/Gynecology

Surgical Gynecological Forceps are hand-held instruments with opposed grasping jaws used in gynecological procedures to grasp, manipulate, and hold tissue structures such as the cervix, uterine wall, or fallopian tubes during diagnostic and therapeutic surgery. They are classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HCZ under regulation 21 CFR 884.4530 in the Obstetrics/Gynecology specialty. These devices are eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: HCZ
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 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172661	Fetzer Medical Gynecological Forceps	May 08, 2018	Substantially Equivalent	Fetzer Medical GmbH & Co. KG
K134047	JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS	Apr 11, 2014	Substantially Equivalent	Integra LifeSciences Corporation
K092840	INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL	Dec 03, 2009	Substantially Equivalent	Instrumed International, Inc.
K944055	FORCEPS, SURGICAL GYNECOLOGICAL	Sep 20, 1994	Substantially Equivalent	Owens Precision Systems, Inc.
K941528	PEARL PACKING FORCEPS	May 12, 1994	Substantially Equivalent	Cook Urological, Inc.
K926533	Z-CLAMP FORCEPS	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926531	HYSTERECTOMY FORCEPS	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926484	CORSON MYOMA GRASPING FORCEPS	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930799	VARIOUS FORCEPS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930039	FORCEPS: MCGRAVEY, MCINDOE, GILLIS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926528	OVUM FORCEPS	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K911474	LAPAROSCOPIC FORCEPS	Jul 03, 1991	Substantially Equivalent	United States Endoscopy Group, Inc.
K903707	DEFLECTING WIRE GRASPER	Sep 26, 1990	Substantially Equivalent	Cook, Inc.
K901897	ZEPPELIN FORCEPS	Jun 29, 1990	Substantially Equivalent	Kirwan Surgical Products, Inc.
K892820	FORCEPS, SURGICAL, GYNECOLOGICAL	Jun 22, 1989	Substantially Equivalent	The South India Surgical Co. Pvt. , Ltd.
K891047	ZEPPELIN FORCEPS	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891036	HYSTERECTOMY FORCEPS - (SEVERAL MODELS)	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K890383	HYSTERECTOMY FORCEPS	Feb 16, 1989	Substantially Equivalent	Kinetic Medical Products
K890386	PLACENTA AND OVUM FORCEPS	Feb 13, 1989	Substantially Equivalent	Kinetic Medical Products
K890378	UTERINE DRESSING FORCEPS	Feb 13, 1989	Substantially Equivalent	Kinetic Medical Products
K852721	BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420	Sep 06, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K834174	OP-CON SURGICAL INSTRUMENTS #4	Dec 27, 1983	Substantially Equivalent	Imm Enterprises , Ltd.
K810391	VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)	Mar 04, 1981	Substantially Equivalent	Edward Weck, Inc.
K772229	MINICLAMPS, STABILIZ., FALLOPIAN TUBE	Jan 03, 1978	Substantially Equivalent	J. Sklar Mfg. Co., Inc.