FDA product code EXA: Selector, Size, Ostomy
EXA is the FDA product code for selector, size, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under EXA. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Selector, Size, Ostomy |
| 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 EXA clearance
Top EXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 1 | 1978-11-03 |
Most recent EXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781736 | C.R. Bard, Inc. | DISC, COLOPLAST PRE-OP STOMA | 1978-11-03 | 22 |
Recalls for EXA devices
openFDA lists no recalls for product code EXA.
Frequently asked questions
What is FDA product code EXA?
EXA is the FDA product code for selector, size, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EXA?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXA?
Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most EXA clearances?
C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXA
- Run a recall and safety report across every EXA manufacturer
- Watch product code EXA 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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