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
FGAClass II

Kit, Nephroscope

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

FGA is the FDA product code for Kit, Nephroscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
FGA
Device name
Kit, Nephroscope
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
10
Ingested recalls
8

Clearances, product code FGA

By decision year
10 clearances under product code FGA with a decision year between 1977 and 2024, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FGA by decision year
YearClearances
19771
19791
19851
19931
19941
19951
20001
20071
20161
20241

Applicants with the most clearances

Product code FGA
Applicants holding the most 510(k) clearances under product code FGA
ApplicantClearances
Karl Storz Endoscopy-America, Inc.2
Richard Wolf Medical Instruments Corp.2
American Cystocope Makers, Inc.1
Gyrus ACMI, Inc.1
Karl Storz SE & Co. KG1
Olympus Corp.1
Optimed Technologies, Inc.1
Schoelly Fiberoptic, GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order