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

Bag, Stomal

21 CFR 876.5900 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GDS is the FDA product code for Bag, Stomal, a class I device type, regulated under 21 CFR 876.5900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GDS
Device name
Bag, Stomal
Regulation
21 CFR 876.5900
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
3

Clearances, product code GDS

By decision year
2 clearances under product code GDS with a decision year between 1988 and 1988, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GDS by decision year
YearClearances
19882

Applicants with the most clearances

Product code GDS
Applicants holding the most 510(k) clearances under product code GDS
ApplicantClearances
Mentor2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order