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

Box, Battery, Pocket

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCP is the FDA product code for Box, Battery, Pocket, a class I device type, regulated under 21 CFR 876.1500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FCP
Device name
Box, Battery, Pocket
Regulation
21 CFR 876.1500
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
2
Ingested recalls
1

Clearances, product code FCP

By decision year
2 clearances under product code FCP with a decision year between 1988 and 1990, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FCP by decision year
YearClearances
19881
19901

Applicants with the most clearances

Product code FCP
Applicants holding the most 510(k) clearances under product code FCP
ApplicantClearances
Dowit Service Co., Inc.1
Lucas & Rhea Mfg.1

Companies listing this code with FDA

Companies whose registered establishments list this code