510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FCWClass II

Light Source, Fiberoptic, Routine

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

FCW is the FDA product code for Light Source, Fiberoptic, Routine, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FCW
Device name
Light Source, Fiberoptic, Routine
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
31
Ingested recalls
5

Clearances, product code FCW

By decision year
31 clearances under product code FCW with a decision year between 1976 and 2014, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FCW by decision year
YearClearances
19762
19771
19831
19841
19851
19871
19891
19901
19911
19944
19951
19961
19972
19992
20001
20011
20031
20082
20091
20101
20122
20131
20141

Applicants with the most clearances

Product code FCW
Applicants holding the most 510(k) clearances under product code FCW
ApplicantClearances
Karl Storz Endoscopy-America, Inc.2
Luxtec Corp.2
Pilling Co.2
Welch Allyn Inc2
Acueity, Inc.1
Angiolaz, Inc.1
Circon Video1
Corin USA1
Cuda Products Co.1
Fiber Imaging Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order