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

Retractor, Fiberoptic

21 CFR 876.4530 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FDG is the FDA product code for Retractor, Fiberoptic, a class I device type, regulated under 21 CFR 876.4530. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FDG
Device name
Retractor, Fiberoptic
Regulation
21 CFR 876.4530
Device class
Class I
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
2
Ingested recalls
2

Clearances, product code FDG

By decision year
2 clearances under product code FDG with a decision year between 1994 and 1997, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FDG by decision year
YearClearances
19941
19971

Applicants with the most clearances

Product code FDG
Applicants holding the most 510(k) clearances under product code FDG
ApplicantClearances
Bioenterics Corp.1
Stephen Chakoff, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order