Product Code: GEN FDA class 1 21 CFR 878.4800

Forceps, General & Plastic Surgery

General, Plastic Surgery

Forceps for General and Plastic Surgery (product code GEN) are manual handheld grasping instruments used across a broad range of general and plastic surgery procedures to hold, manipulate, or retract tissue and surgical materials. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only with no premarket notification required. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery specialty (SU), this instrument carries no special regulatory flags.

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510(k)s

104

FEI Numbers

444

Registration Numbers

445

Unique Applicants

Years Active

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Basic Information

Product Code: GEN
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 104 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K031828	NATURALASE LP ND:YAG LASER	Jul 17, 2003	Substantially Equivalent	Focus Medical, LLC
K953962	FORCEPS	Sep 08, 1995	Substantially Equivalent	Biopsys Medical, Inc.
K932385	SUTURE REMOVING FORCEPS	Aug 06, 1993	Substantially Equivalent	Rocket of London, Ltd.
K904723	FORCEPS	Jul 26, 1991	Substantially Equivalent	Minto Research & Development, Inc.
K911159	PALPATION PROBE	Mar 29, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K900960	GS-1500 CLAW FORCEP, 10MM	Apr 18, 1990	Substantially Equivalent	Solos Endoscopy, Inc.
K900952	GS-1200 GRASPING/EXTRACTING FORCEP, 10MM	Apr 18, 1990	Substantially Equivalent	Solos Endoscopy, Inc.
K900951	GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP	Apr 18, 1990	Substantially Equivalent	Solos Endoscopy, Inc.
K900948	GS-1002 GRASPING FORCEP, 5MM WITH RATCHET	Apr 18, 1990	Substantially Equivalent	Solos Endoscopy, Inc.
K891896	TISSUE FORCEPS, VARIOUS TYPES	Apr 12, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891401	HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT	Apr 06, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K891348	CAMPION LASER FORCEPS	Mar 22, 1989	Substantially Equivalent	Simpson/Basye, Inc.
K884514	FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL	Nov 17, 1988	Substantially Equivalent	Gatewood and Associates, Ltd.
K884181	MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)	Nov 10, 1988	Substantially Equivalent	Sales & Marketing Assoc.
K884195	GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)	Oct 24, 1988	Substantially Equivalent	Mumtaz I. Malik
K875319	NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS	Jan 22, 1988	Substantially Equivalent	I-Tech Industries, Inc.
K874634	NSN #6515-00-333-2400 ADSON DRESSING FORCEPS	Dec 02, 1987	Substantially Equivalent	I-Tech Industries, Inc.
K873978	DISPOSABLE BIPOLAR FORCEPS	Nov 23, 1987	Substantially Equivalent	E.M. Adams
K872991	MICRINS FORCEPS 2010	Aug 17, 1987	Substantially Equivalent	Micrins Surgical, Inc.
K872271	VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS	Jun 26, 1987	Substantially Equivalent	New England Surgical Instrument Corp.
K871927	CUP BIOPSY FORCEP, 1.7MM	Jun 09, 1987	Substantially Equivalent	Arthropedics, Inc.
K871926	GRASPING FORCEP, 1.7MM	Jun 09, 1987	Substantially Equivalent	Arthropedics, Inc.
K864608	ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP	Dec 16, 1986	Substantially Equivalent	Adobe Ent.
K861805	MEDCARE FORCEPS (THUMB, TISSUE)	May 23, 1986	Substantially Equivalent	Medcomp Technologies, Inc.
K854916	PILLING HEMOSTATIC CLIP APPLIER FORCEPS	Jan 24, 1986	Substantially Equivalent	Pilling Co.
K854541	TIP OFF FORCEPS	Dec 17, 1985	Substantially Equivalent	Keller Instruments, Inc.
K854146	SURGICAL & DENTAL INSTRUMENT	Nov 13, 1985	Substantially Equivalent	Baort, Inc.
K853153	MEDUS GMBH	Aug 07, 1985	Substantially Equivalent	Corkes Medical Co.
K853015	SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420	Jul 29, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852730	CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852717	IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852120	FORCEPS, BIOPSY(NON RIGID)	Jul 02, 1985	Substantially Equivalent	Scholten Surgical Instruments, Inc.
K851728	2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS	Jul 01, 1985	Substantially Equivalent	Artiberia
K852531	NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410	Jun 28, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851796	51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO	Jun 20, 1985	Substantially Equivalent	Artiberia
K851793	39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS	Jun 20, 1985	Substantially Equivalent	Artiberia
K851773	17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI	Jun 20, 1985	Substantially Equivalent	Artiberia
K851772	17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS	Jun 20, 1985	Substantially Equivalent	Artiberia
K851771	15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST	Jun 20, 1985	Substantially Equivalent	Artiberia
K851673	RAKA OCH BOSDA PEANGER	May 29, 1985	Substantially Equivalent	General Electric Trading Co.
K851170	DISSECTING TWEEZER #283-72PCS. SS 410	Apr 25, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851116	JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42	Apr 25, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851114	MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420	Apr 25, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851106	PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F	Apr 25, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K844062	FORCEPS & HAMOSTATS	Jan 18, 1985	Substantially Equivalent	I M, Inc.
K843074	DISPOS. & SPONGE FORCEPS PEAN ARTERY	Aug 17, 1984	Substantially Equivalent	Greene International Corp.
K834095	BIOPSY FORCEPS	Jan 27, 1984	Substantially Equivalent	Micro Vasive, Inc.
K833542	SURGICAL INSTRUMENT	Nov 28, 1983	Substantially Equivalent	Hirata Sangyo Co. USA, Inc.
K831805	GENERAL SURGICAL INSTRUMENTS	Jul 14, 1983	Substantially Equivalent	Aim Corp.
K822591	TISSUE FORCEPS	Oct 13, 1982	Substantially Equivalent	Medcare Products
K822491	DISPOSABLE GRASPING FORCEPS	Sep 17, 1982	Substantially Equivalent	Van-Tec, Inc.
K822278	ENT FORCEPS	Aug 27, 1982	Substantially Equivalent	Kelleher Corp.
K821248	ROCHESTER PEAN FORCEPS	May 28, 1982	Substantially Equivalent	Conphar, Inc.
K821353	CONPHAR ALLIS FORCEPS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821339	SALMONELLA POLY	May 27, 1982	Substantially Equivalent	Analytical Products, Inc.
K821296	ROCHESTER PEAN FORCEPS CURVED 6 1/4	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821287	CRILE FORCEPS STRAIGHT 5 1/2	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821283	HARTMAN FORCEPS (MOSQUITO)	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821281	CRILE, CURVED FORCEPS 5 1/2	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821280	TISSUE FORCEPS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821279	HALSTEAD FORCEPS (MOSQUITO) 5	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821278	HARTMAN FORCEPS STRAIGHT 3 1/2	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821277	KELLY FORCEPS CURVED 5 1/2	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821274	HALSTEAD MOSQUITO FORCEPS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821267	THUMB DRESSING FORCEPS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821349	CONPHAR FOERSTER FORCEPS	May 25, 1982	Substantially Equivalent	Conphar, Inc.
K821288	TUBE OCCULDING FORCEPS 7	May 25, 1982	Substantially Equivalent	Conphar, Inc.
K821143	DISPOSABLE THUMB FORCEPS	May 21, 1982	Substantially Equivalent	Medcare Products
K820980	BIOPSY FORCEPS W/OVAL CUP & NEEDLE	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K820972	BIOPSY FORCEPS W/OVAL CUPS	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K820970	RETRIEVAL FORCEPS W/RATTOOTHED JAWS	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K820969	BIOPSY FORCEPW W/SMALL OVAL CUPS	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K820968	RETRIEVAL FORCEPS W/ALLIGATOR JAWS	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K820967	BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS	Apr 26, 1982	Substantially Equivalent	Mill-Rose Laboratory
K813245	O'CONNOR HOOK PUNCH FORCEP	Dec 29, 1981	Substantially Equivalent	Shutt Instruments
K812785	VANCE-AMBROSE RESECTOSCOPE FORCEPS	Nov 16, 1981	Substantially Equivalent	Vance Products, Inc.
K812205	FORCEP	Oct 26, 1981	Substantially Equivalent	Reznik Instruments
K811686	SURGICAL INSTRUMENTS	Jul 20, 1981	Substantially Equivalent	C.V.I., Inc.
K810685	SUTURE REMOVAL KIT	Mar 26, 1981	Substantially Equivalent	Medical Action Industries, Inc.
K801991	PLASTIC FORCEPS CAT.#1001-1010	Sep 16, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K801075	STRAITH CHISEL FORCEPS	May 20, 1980	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K800647	NORSEN DEBRIDER	Apr 16, 1980	Substantially Equivalent	Medline Industries, Inc.
K800435	HEMOSTATIC/TUBE OCCLUDING FORCEPS	Mar 12, 1980	Substantially Equivalent	Dravon Medical, Inc.
K792494	CATHETERIZATION FORCEP	Dec 20, 1979	Substantially Equivalent	C. Intl.
K792309	CASTROVIEJO VASCULAR NEEDLEHOLDER 538425	Nov 30, 1979	Substantially Equivalent	Edward Weck, Inc.
K792100	GRASPING FORCEP (W/FOUR PRONGS)	Nov 13, 1979	Substantially Equivalent	Eder Instrument Co, Inc.
K791987	VASCULAR FORCEPS & CLAMPS	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K790854	FORCEPS #101 AND #102	Jun 05, 1979	Substantially Equivalent	C. Intl.
K781448	HARRINGTON HOOK CLAMP	Sep 27, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K781447	THREADED ROD CLAMP	Sep 27, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K781446	C RING CLINCHER	Sep 27, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K772393	CARROLL TENDON RETRIEVER	May 09, 1978	Substantially Equivalent	Edward Weck, Inc.
K772383	LONG JEWELERS FORCEPS	Mar 09, 1978	Substantially Equivalent	Edward Weck, Inc.
K771515	SUTURE TISSUE APPROXIMATING FORCEP	Sep 30, 1977	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K771746	FORCEPS	Sep 26, 1977	Substantially Equivalent	Depuy, Inc.
K771691	ANGLED FORCEP APPLIER	Sep 22, 1977	Substantially Equivalent	Edward Weck, Inc.
K771624	COPE LUNG FORCEPS #305-218	Sep 06, 1977	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K770540	FORCEPS, MOSQUITO STYLE, 12.5 CM.	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770539	FORCEPS, HAEM, DEEP OPERATION, 20&22 CM.	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770538	FORCEPS, HAEMOSTATIC, 14 16,&18 CM. LONG	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770329	WOMB PREP KIT	Apr 05, 1977	Substantially Equivalent	American Hospital Supply Corp.
K761334	MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT	Feb 24, 1977	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K760507	FORCEP, THUMB	Nov 12, 1976	Substantially Equivalent	Acme United Corp.
K760703	SPONGE AND GAUZE FORCEP PART #S-417-9	Oct 21, 1976	Substantially Equivalent	Acme United Corp.