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

Box, Battery, Rechargeable

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

FCO is the FDA product code for Box, Battery, Rechargeable, a class I device type, regulated under 21 CFR 876.1500. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCO
Device name
Box, Battery, Rechargeable
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
20
Ingested recalls
0

Clearances, product code FCO

By decision year
20 clearances under product code FCO with a decision year between 1993 and 1995, 1995 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code FCO by decision year
YearClearances
19931
19948
199511

Applicants with the most clearances

Product code FCO
Applicants holding the most 510(k) clearances under product code FCO
ApplicantClearances
R & D Batteries, Inc.17
National Custom Ent., Inc.2
Portable Power Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code