OLL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Septal Stapler/Absorbable Staples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
- Adverse events (MAUDE)
- 2014: 7
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 |
|---|---|---|
| ENTACT SEPTAL STAPLER, MODEL 610-00100 (K082750) | Entrigue Surgical, Inc. | 2009-01-06 |
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