Product Code: GDJ FDA class 1 21 CFR 878.4800

Clamp, Surgical, General & Plastic Surgery

General, Plastic Surgery

The Clamp, Surgical, General and Plastic Surgery (product code GDJ) is a surgical instrument used to compress, occlude, or secure tissue, vessels, or other structures during general or plastic surgery procedures, providing hemostasis or holding tissue in place during operations. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

270

Registration Numbers

270

Unique Applicants

Years Active

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Basic Information

Product Code: GDJ
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

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 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153358	Standard Clamp	May 02, 2016	Substantially Equivalent	Standard Bariatrics
K930315	THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE	Feb 04, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K924223	MAR-MED LIVER STRAP	Mar 18, 1993	Substantially Equivalent	Mar-Med Co.
K922659	GENERAL SURGERY CLAMP AND NEEDLE HOLDER	Jul 21, 1992	Substantially Equivalent	Miltex Instrument Co.
K914913	GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST	Dec 31, 1991	Substantially Equivalent	Ideal Medical, Inc.
K900956	GS-7100 CHOLANGIOGRAM CLAMP, 5MM	Apr 18, 1990	Substantially Equivalent	Solos Endoscopy, Inc.
K901107	MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC	Apr 09, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K895726	VESSEL OCCLUDER	Oct 24, 1989	Substantially Equivalent	Applied Medical Technologies
K895591	SILICONE INSTRUMENT SHODS	Oct 20, 1989	Substantially Equivalent	Key Surgical, Inc.
K882169	SURGICAL DUCT CLAMP (VINE)	Jun 17, 1988	Substantially Equivalent	Henley Intl.
K881741	STUART LEE CLIP	Jun 03, 1988	Substantially Equivalent	Stuart-Lee, Inc.
K881084	UTILITY CLAMP	Mar 25, 1988	Substantially Equivalent	Med-Dex Intl.
K874428	AUTO SUTURE PURSE STRING APPLIER*	Dec 02, 1987	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K855144	TOURIQUET KIT WITH SNARE	Feb 05, 1986	Substantially Equivalent	Dlp, Inc.
K853583	MODERN MEDICAL PRODUCTS TOWEL CLAMP	Sep 16, 1985	Substantially Equivalent	Modern Medical Products
K852724	BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851774	17-900 TO 17-980 VARIOUS TOWEL CLAMPS	Jun 20, 1985	Substantially Equivalent	Artiberia
K843816	TAL-CLIP	Oct 31, 1984	Substantially Equivalent	Talboy, Inc.
K812388	SURGICAL PAWS	Nov 16, 1981	Substantially Equivalent	Berkeley Medevices
K801660	PROXIMATE * PSD PURSE-STRING DEVICE	Aug 13, 1980	Substantially Equivalent	ETHICON, Inc.
K800074	VESSEL OCCLUDER	Jan 28, 1980	Substantially Equivalent	Cordis Corp.
K791802	CONPHAR TUBE CLAMPS	Sep 21, 1979	Substantially Equivalent	Conphar, Inc.
K791800	CONPHAR UMBILICAL CORD CLAMP	Sep 21, 1979	Substantially Equivalent	Conphar, Inc.
K782006	MEDGENERAL SINGLE-USE BULLDOG	Dec 15, 1978	Substantially Equivalent	Med General
K780721	IDENTI-CLAMPS	Oct 17, 1978	Substantially Equivalent	Berkeley Bio-Medical, Inc.
K780291	ULNAR-RADIAL APPROXIMATER	Feb 28, 1978	Substantially Equivalent	Edward Weck, Inc.
K780290	ULNAR-RADIAL CLIP	Feb 28, 1978	Substantially Equivalent	Edward Weck, Inc.
K780288	BRACHEAL-LARGE VESSEL CLIP	Feb 28, 1978	Substantially Equivalent	Edward Weck, Inc.
K780286	BRACHIAL-LARGE VESSEL APPROXIMATOR	Feb 28, 1978	Substantially Equivalent	Edward Weck, Inc.
K771701	VESSEL-CLUDE	Dec 13, 1977	Substantially Equivalent	Med General
K771589	AUTO SUTURE	Dec 13, 1977	Substantially Equivalent	U. S. Surgical Corp.
K760898	GOLDFARB LIVER CLAMP	Dec 29, 1976	Substantially Equivalent	Edward Weck, Inc.