Product Code: HTD FDA class 1 21 CFR 878.4800

Forceps

General, Plastic Surgery

Forceps are handheld surgical instruments with two opposing blades used to grasp, hold, or manipulate tissue and other materials during surgical procedures. They are classified as an FDA Class 1 device under 21 CFR 878.4800, indicating the lowest level of risk and general controls only. Product code HTD falls under the General and Plastic Surgery medical specialty.

View on FDA

510(k)s

FEI Numbers

658

Registration Numbers

658

Unique Applicants

Years Active

Research product code HTD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HTD
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 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K051281	THE NEEDLE CATCHER	Sep 08, 2005	Substantially Equivalent	E.D.Medical , Ltd.
K974595	CUSHING BAYONET, INSULATED BIPOLAR FORCEP	Jun 24, 1998	Substantially Equivalent	Titan Mfg., Inc.
K974594	SEMKIN BIPOLAR FORCEP	Jun 24, 1998	Substantially Equivalent	Titan Mfg., Inc.
K974593	SEMKIN INSULATED BIPOLAR FORCEP	Jun 24, 1998	Substantially Equivalent	Titan Mfg., Inc.
K913964	MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS	Oct 23, 1991	Substantially Equivalent	Marlo Surgical Technology
K911180	CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS	Mar 29, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K895212	TIK EXTRAKTOR	Sep 27, 1989	Substantially Equivalent	Instruments of Sweden, Inc.
K890373	HEMORRHOIDAL FORCEPS	Feb 03, 1989	Substantially Equivalent	Kinetic Medical Products
K890369	GALL STONE FORCEPS	Feb 03, 1989	Substantially Equivalent	Kinetic Medical Products
K890263	CILIA FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890262	LUNG FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890260	BONE SHEARS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890259	RIB SHEARS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890258	BONE CUTTING FORCEPS, SINGLE-ACTION	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890257	BONE CUTTING FORCEPS, DOUBLE-ACTION	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890246	ARTERY FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890244	TUBING CLAMP FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890238	CATHETER FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890234	SUTURE CLIP REMOVER	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890226	SURGICAL FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K890213	MICROSURGICAL FORCEPS	Jan 27, 1989	Substantially Equivalent	Kinetic Medical Products
K874965	MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE	Dec 30, 1987	Substantially Equivalent	Solway, Inc.
K874950	MICROSURGICAL INSTRUMENTS	Dec 30, 1987	Substantially Equivalent	Solway, Inc.
K874023	LEVTECH CLAMP APPLIER	Nov 06, 1987	Substantially Equivalent	Levtech, Inc.
K873513	SERRATED GRASPING FORCEPS, CURVED UP	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873512	SERRATED GRASPING FORCEPS, RIGHT	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873511	SERRATED GRASPING FORCEPS, LEFT	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873510	SERRATED GRASPING FORCEPS, CURVED DOWN	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873506	CUP BIOPSY FORCEPS, CURVED UP	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873505	CUP BIOPSY FORCEPS, CURVED DOWN	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873504	CUP BIOPSY FORCEPS, RIGHT	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K873503	CUP BIOPSY FORCEPS, LEFT	Nov 02, 1987	Substantially Equivalent	Arthropedics, Inc.
K871535	SMILJANIC BONE REPOSITIONING FORCEPS	May 14, 1987	Substantially Equivalent	Link America, Inc.
K870881	LOOSE BODY GRASPERS	Mar 23, 1987	Substantially Equivalent	Bowen & Company, Inc.
K852729	AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852728	KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852727	ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852723	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852722	STERILIZING FORCEPS, 3-PRONGE, 11+SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852720	THUMB DRESSING FORCEPS, 5+SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852718	ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852715	MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852713	RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420	Jul 15, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K851770	VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA	Jun 20, 1985	Substantially Equivalent	Artiberia
K851769	VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR	Jun 20, 1985	Substantially Equivalent	Artiberia
K842819	HOOK PUNCH FORCEPS FOR ARTHROSCOPY	Aug 14, 1984	Substantially Equivalent	Medtech Industries, Inc.
K834367	SUTURE REMOVAL WOUND CLOSURE-INSTRU-	May 30, 1984	Substantially Equivalent	Sterling Multi-Products, Inc.
K840304	CATEGORY 17-MICROBIOLOGY DEVICES	May 01, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840766	JANACEK TUBO-UTERINE IMPLANTATION SET	Apr 23, 1984	Substantially Equivalent	Cimed Intl., Inc.
K840318	CAT. 14-CLINICAL TOXIOLOGY DEVICES	Apr 23, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840320	CAT. 16-IMMUNOLOGY DEVICES	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840319	CAT 15-HEMATOLOGY & PATHOLOGY DEVICE	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840317	CAT 13-CLINICAL CHEMISTRY DEVICES	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840316	CAT 12-ORTHOPEDIC & REHAB DEVICE	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840315	CAT 11- GENERAL & PLASTIC SURGERY DEV	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840309	CAT. 5-RADIOLOGY DEVICES	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840307	CAT. 3 GASTROENTEROLOGY-UROLOGY DEV	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K840306	CATEGORY 2 GEN. HOSPITAL & PERSONAL USE	Mar 12, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K833629	CERTAIN MANUAL SURG. INSTRU. ACCESS	Jan 30, 1984	Substantially Equivalent	Cimed Intl., Inc.
K834542	H.R. JAKOBI SURG. INSTRU. SECT. 48	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834185	JAKOBI SURG. INSTRUMENTS #11 14/45	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834183	H.R. JAKOBI SURG. INSTRUMENTS #11 25/39	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K834180	H.R. JAKOBI SURG. INSTRUMENTS #11 13/20	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K831138	CURVED HEMOSTAT 5	May 18, 1983	Substantially Equivalent	Almore Intl., Inc.
K831137	STRAIGHT 5 HEMOSTAT	May 18, 1983	Substantially Equivalent	Almore Intl., Inc.
K821298	BACKHAUS CLAMP, 3 1/2	May 28, 1982	Substantially Equivalent	Conphar, Inc.
K821293	BACKHAUS CLAMP, 5 1/4	May 28, 1982	Substantially Equivalent	Conphar, Inc.
K820344	ROWE SHOULDER INSTR. FOR BANKHART REPAIR	Mar 08, 1982	Substantially Equivalent	New England Surgical Instrument Corp.
K802676	ORHTOPEDIC REAMER 87 HTD	Nov 12, 1980	Substantially Equivalent	Zimmer, Inc.
K800273	ACUFEX FORCEPS	Feb 19, 1980	Substantially Equivalent	Acufex Microsurgical, Inc.
K771097	FORCEP, DISP., A CLAMP	Jul 14, 1977	Substantially Equivalent	Dravon Medical, Inc.
K771192	LOWMAN BONE FORCEP	Jul 11, 1977	Substantially Equivalent	Edward Weck, Inc.
K770206	GRASPING FORCEPS	Feb 08, 1977	Substantially Equivalent	Depuy, Inc.