Product Code: FCF FDA class 2 21 CFR 876.1075

Instrument, Biopsy, Mechanical, Gastrointestinal

Gastroenterology, Urology

The Mechanical Gastrointestinal Biopsy Instrument (product code FCF) is a device used to obtain tissue samples from the gastrointestinal tract by mechanical means, typically through an endoscope, for pathological evaluation. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FCF
Device Class: FDA class 2
Regulation Number: 876.1075
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
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 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K070759	POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM	May 21, 2007	Substantially Equivalent	Vidacare Corporation
K062833	POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM	Nov 30, 2006	Substantially Equivalent	Vidacare Corporation
K984168	BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE	Dec 07, 1999	Substantially Equivalent	United States Endoscopy Group, Inc.
K915142	AMCATH DISPOSABLE BIOPSY FORCEPS	Jan 10, 1992	Substantially Equivalent	Intl. Medical, Inc.
K911155	OVAL CUP BIOPSY FORCEP	Aug 07, 1991	Substantially Equivalent	Endovations
K843477	PHARMA-PLAST RECTAL TIP	Dec 05, 1984	Substantially Equivalent	Zimmar Consulting , Ltd.