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

Urethroscope

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

FGC is the FDA product code for Urethroscope, 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
FGC
Device name
Urethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FGC

By decision year
3 clearances under product code FGC with a decision year between 1980 and 2009, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FGC by decision year
YearClearances
19801
19951
20091

Applicants with the most clearances

Product code FGC
Applicants holding the most 510(k) clearances under product code FGC
ApplicantClearances
Karl Storz Endoscopy-America, Inc.1
Kli1
Percuvision, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code