Product Code: FCL FDA class 1 21 CFR 876.1075

Forceps, Biopsy, Non-Electric

Gastroenterology, Urology

The Non-Electric Biopsy Forceps (product code FCL) is a manually operated grasping instrument used to obtain tissue samples from the gastrointestinal or genitourinary tract without the use of electrical energy. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. No special flags apply.

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510(k)s

FEI Numbers

188

Registration Numbers

188

Unique Applicants

Years Active

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Basic Information

Product Code: FCL
Device Class: FDA class 1
Regulation Number: 876.1075
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K032092	OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE	Jul 16, 2003	Substantially Equivalent	Olympus Optical Co., Ltd.
K973611	SPECTRASCIENCE REUSABLE BIOPSY FORCEPS	Dec 02, 1997	Substantially Equivalent	Spectrascience, Inc.
K971315	AUXILIARY INSTRUMENTS FOR URS	Sep 15, 1997	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K964120	INJECTO FLUSH	Dec 30, 1996	Substantially Equivalent	Robert J. Jynch, Jr.
K963517	SPECTRA SCIENCE BIOPSY FORCEPS	Dec 02, 1996	Substantially Equivalent	Spectrascience, Inc.
K955065	OLYMPUS FB SERIES BIOPSY FORCEPS	Jan 24, 1996	Substantially Equivalent	Olympus America, Inc.
K952863	FORCEPS, BIOPSY, NON-ELECTRIC	Jul 19, 1995	Substantially Equivalent	Annex Medical, Inc.
K952391	DYNABITE UROLOGICAL FORCEPS	Jun 01, 1995	Substantially Equivalent	Portlyn Corp.
K951048	RITE-BITE BIOPSY FORCEPS	Mar 15, 1995	Substantially Equivalent	Mill-Rose Laboratory
K946360	MODULAR BIOPSY FORCEP	Mar 06, 1995	Substantially Equivalent	Cox Medical Ent., Inc.
K950559	DIENER RETRIEVAL DEVICES	Feb 16, 1995	Substantially Equivalent	Mill-Rose Laboratory
K946238	SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS	Jan 20, 1995	Substantially Equivalent	Symbiosis Corp.
K944770	LSVP INTERNATIONAL BIOPSY FORCEPS	Oct 13, 1994	Substantially Equivalent	Lsvp Intl., Inc.
K941816	EMC FLEXIBLE BIOPSY FORCEPS	Jul 13, 1994	Substantially Equivalent	Enterprise Medical Corp.
K941359	GIP/MEDI-GLOBE BIOPSY FORCEPS	Jul 12, 1994	Substantially Equivalent	Medi-Globe Corp.
K933135	DAWN DISPOSABLE BIOPSY FORCEPS	Mar 07, 1994	Substantially Equivalent	Dawn Medical
K931957	SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS	Feb 28, 1994	Substantially Equivalent	Symbiosis Corp.
K935070	GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS	Jan 25, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K935250	ACCU-PATH	Jan 21, 1994	Substantially Equivalent	Cox Medical Ent., Inc.
K934186	FORCEPS, BIOPSY, GASTROINTESTINAL	Dec 14, 1993	Substantially Equivalent	Primed Instruments, Inc.
K925392	BIOPSY FORCEPS	Nov 05, 1993	Substantially Equivalent	Endo-Therapeutics, Inc.
K932265	SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND	Aug 09, 1993	Substantially Equivalent	Symbiosis Corp.
K922396	FUJINON FORCEPS -- MODIFICATION	Dec 10, 1992	Substantially Equivalent	Hobbs Medical, Inc.
K914497	BIOPSY FORCEPS	Jan 03, 1992	Substantially Equivalent	Surgitek Medical Engineering Corp.
K914212	BARD SINGULAR BIOPSY FORCEPS	Nov 27, 1991	Substantially Equivalent	C.R. Bard, Inc.
K913883	COX DISPOSABLE BIOPSY FORCEP	Oct 05, 1991	Substantially Equivalent	Cox Medical Ent., Inc.
K912549	BARD(R) DISPOSABLE BIOPSY FORCEPS	Sep 10, 1991	Substantially Equivalent	C.R. Bard, Inc.
K912214	BARD SINGULAR BIOPSY FORCEPS	May 30, 1991	Substantially Equivalent	C.R. Bard, Inc.
K896147	BIOPSY FORCEP (NON-ELECTRIC)	Apr 16, 1990	Substantially Equivalent	Portlyn Corp.
K893636	GUARDIAN FORCEP	Apr 09, 1990	Substantially Equivalent	Endo-Scientific, Inc.
K900065	NON-ELECTRIC BIOPSY FORCEPS	Mar 15, 1990	Substantially Equivalent	Esco Precision, Inc.
K900015	NON-ELECTRIC BIOPSY FORCEPS	Mar 15, 1990	Substantially Equivalent	Esco Precision, Inc.
K892252	BIOPSY FORCEPS	Oct 03, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K873176	HUFFMAN BIOPSY UNIT	Oct 14, 1987	Substantially Equivalent	Penn Medical Devices, Inc.
K871710	BIOPSY FORCEPS	Aug 10, 1987	Substantially Equivalent	Frantz Medical Development, Ltd.
K844551	HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT	Jan 03, 1985	Substantially Equivalent	Gobbs Medical, Inc.
K844690	ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT	Jan 02, 1985	Substantially Equivalent	Jayco Pharmaceuticals
K840818	BIOPSY FORCEPS	Apr 13, 1984	Substantially Equivalent	American Endoscopy, Inc.
K800963	BIOPSY FORCEPS W/NEEDLE M.R. ASSOC.	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.