FDA product code EXN: Support, Hernia
EXN is the FDA product code for support, hernia. It is a Class I device, regulated under 21 CFR 876.5970 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under EXN. The average 510(k) review took 179 days (median 179).
Classification
| Field | Value |
|---|---|
| Device name | Support, Hernia |
| Device class | Class I |
| Regulation | 21 CFR 876.5970 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EXN clearance
Top EXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safte S.P.A. | 1 | 1990-10-26 |
Most recent EXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901922 | Safte S.P.A. | SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 | 1990-10-26 | 179 |
Recalls for EXN devices
openFDA lists no recalls for product code EXN.
Frequently asked questions
What is FDA product code EXN?
EXN is the FDA product code for support, hernia. It is a Class I device, regulated under 21 CFR 876.5970 and reviewed by the Gastroenterology and Urology panel.
What device class is EXN?
Class I, regulation 21 CFR 876.5970. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXN?
Across 1 cleared submissions the average was 179 days from receipt to decision (median 179).
Which companies have the most EXN clearances?
Safte S.P.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXN
- Run a recall and safety report across every EXN manufacturer
- Watch product code EXN 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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