510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FCFClass II

Instrument, Biopsy, Mechanical, Gastrointestinal

21 CFR 876.1075 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCF is the FDA product code for Instrument, Biopsy, Mechanical, Gastrointestinal, a class II device type, regulated under 21 CFR 876.1075. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCF
Device name
Instrument, Biopsy, Mechanical, Gastrointestinal
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code FCF

By decision year
6 clearances under product code FCF with a decision year between 1984 and 2007, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FCF by decision year
YearClearances
19841
19911
19921
19991
20061
20071

Applicants with the most clearances

Product code FCF
Applicants holding the most 510(k) clearances under product code FCF
ApplicantClearances
Teleflex Medical2
Endovations1
Intl. Medical, Inc.1
United States Endoscopy Group, Inc.1
Zimmar Consulting, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code