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

Light Source, Photographic, Fiberoptic

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

FCR is the FDA product code for Light Source, Photographic, Fiberoptic, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCR
Device name
Light Source, Photographic, Fiberoptic
Regulation
21 CFR 876.1500
Device class
Class II
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
3
Ingested recalls
0

Clearances, product code FCR

By decision year
3 clearances under product code FCR with a decision year between 1982 and 1985, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCR by decision year
YearClearances
19822
19851

Applicants with the most clearances

Product code FCR
Applicants holding the most 510(k) clearances under product code FCR
ApplicantClearances
Warner-Lambert Co.2
Mecron Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code