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
FGSClass II

Carrier, Sponge, Endoscopic

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

FGS is the FDA product code for Carrier, Sponge, Endoscopic, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FGS
Device name
Carrier, Sponge, Endoscopic
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
4
Ingested recalls
1

Clearances, product code FGS

By decision year
4 clearances under product code FGS with a decision year between 1982 and 1993, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FGS by decision year
YearClearances
19821
19933

Applicants with the most clearances

Product code FGS
Applicants holding the most 510(k) clearances under product code FGS
ApplicantClearances
Joyce M. Shotwell, M.D.1
Kelleher Corp.1
Mayaguez Medical Center1
O.R. Concepts, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code