GBN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Pediatric, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MEDDRAINS (K931607) | Armm, Inc. | 1993-08-06 |
| SURGEONS CHOICE STAPLE, REMOVE/IMPLANT (K802783) | Hospital Products Intl. | 1980-12-16 |
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Every clearance here is in the API, with alerts when new ones post.