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

Forceps, Biopsy, Non-Electric

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

FCL is the FDA product code for Forceps, Biopsy, Non-Electric, a class I device type, regulated under 21 CFR 876.1075. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
FCL
Device name
Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
39
Ingested recalls
11

Clearances, product code FCL

By decision year
39 clearances under product code FCL with a decision year between 1980 and 2003, 1994 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code FCL by decision year
YearClearances
19801
19841
19852
19872
19891
19904
19914
19922
19933
19947
19956
19963
19972
20031

Applicants with the most clearances

Product code FCL
Applicants holding the most 510(k) clearances under product code FCL
ApplicantClearances
C.R. Bard Inc3
Cox Medical Ent., Inc.3
Boston Scientific Corporation3
Esco Precision, Inc.2
Mill-Rose Laboratory2
Portlyn Corp.2
Spectrascience, Inc.2
American Endoscopy, Inc.1
Annex Medical, Inc.1
Dawn Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 176 companies shown, in name order