FAX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bougie, Urological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5520
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1998: 1 · 2000: 2 · 2002: 2 · 2003: 4 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| KARL STORZ BOUGIES AND DILATORS (K950125) | KARL STORZ Endoscopy-America, Inc. | 1995-02-07 | + Add |
| ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL (K822711) | Parker Laboratories, Inc. | 1982-11-03 | + Add |
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Every clearance here is in the API, with alerts when new ones post.