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

Punch, Biopsy

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

FCI is the FDA product code for Punch, Biopsy, a class II device type, regulated under 21 CFR 876.1075. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCI
Device name
Punch, Biopsy
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
5
Ingested recalls
0

Clearances, product code FCI

By decision year
5 clearances under product code FCI with a decision year between 1983 and 1990, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FCI by decision year
YearClearances
19831
19851
19881
19891
19901

Applicants with the most clearances

Product code FCI
Applicants holding the most 510(k) clearances under product code FCI
ApplicantClearances
Advanced Diagnostic Medical Systems, Inc.1
August C. Stiefel Research Institute, Inc.1
Diasonics, Inc.1
Integrated Display Technology, Ltd.1
National-Standard Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FCI.