FDA product code GDS: Bag, Stomal
GDS is the FDA product code for bag, stomal. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under GDS. The average 510(k) review took 204 days (median 204). FDA has posted 3 recalls for GDS devices.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Stomal |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GDS clearance
Top GDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mentor Corp. | 2 | 1988-09-29 |
Most recent GDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883023 | Mentor Corp. | MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND | 1988-09-29 | 72 |
| K871313 | Mentor Corp. | ULTRA-FRESH DEODORANT | 1988-03-02 | 336 |
Recalls for GDS devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-08-16.
Frequently asked questions
What is FDA product code GDS?
GDS is the FDA product code for bag, stomal. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is GDS?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDS?
Across 2 cleared submissions the average was 204 days from receipt to decision (median 204).
Which companies have the most GDS clearances?
Mentor Corp. (2).
Have GDS devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2010-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code GDS
- Run a recall and safety report across every GDS manufacturer
- Watch product code GDS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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