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
FCSClass II

Light, Catheter, Fiberoptic, Glass, Ureteral

21 CFR 876.4020 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCS is the FDA product code for Light, Catheter, Fiberoptic, Glass, Ureteral, a class II device type, regulated under 21 CFR 876.4020. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FCS
Device name
Light, Catheter, Fiberoptic, Glass, Ureteral
Regulation
21 CFR 876.4020
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
10
Ingested recalls
3

Clearances, product code FCS

By decision year
10 clearances under product code FCS with a decision year between 1988 and 2015, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCS by decision year
YearClearances
19882
19931
19942
19952
19981
20061
20151

Applicants with the most clearances

Product code FCS
Applicants holding the most 510(k) clearances under product code FCS
ApplicantClearances
Stryker Corp.3
Gabriel Medical, Inc.2
CooperSurgical, Inc.1
Cook Incorporated1
Laser Peripherals LLC1
Laserguide1
Rocket of London, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code