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

Biopsy Needle

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

FCG is the FDA product code for Biopsy Needle, a class II device type, regulated under 21 CFR 876.1075. As of , FDA records hold 133 510(k) clearances under this code, the most recent dated , and 54 recalls.

Classification record

Product code
FCG
Device name
Biopsy Needle
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
133
Ingested recalls
54

Clearances, product code FCG

By decision year
133 clearances under product code FCG with a decision year between 1977 and 2025, 1995 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code FCG by decision year
YearClearances
19771
19803
19845
19853
19871
19881
19896
19903
19913
19922
19931
19949
199512
19966
19975
19982
19992
20003
20018
20024
20031
20041
20055
20074
20081
20094
20103
20111
20131
20145
20154
20163
20173
20186
20201
20211
20222
20234
20241
20252

Applicants with the most clearances

Product code FCG
Applicants holding the most 510(k) clearances under product code FCG
ApplicantClearances
Cook Ireland Ltd.7
Medi-Globe GmbH7
Olympus Medical Systems Corp.7
Wilson-Cook Medical Inc.6
Boston Scientific Corporation5
H.S. Hospital Service S.p.A.4
H.S. Hospital Services S.p.A.4
Promex, Inc.4
A.D.T. Lab Industries3
Finemedix3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 101 companies shown, in name order