EXN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Support, Hernia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5970
- Medical specialty
- Gastroenterology, Urology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 1 · 1998: 2 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 (K901922) | Safte S.P.A. | 1990-10-26 | + Add |
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