NLL
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Staple, Implantable, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS (K070930) | Sterilmed, Inc. | 2007-10-18 |
| REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS (K070859) | Sterilmed, Inc. | 2007-09-12 |
| REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (K033578) | Clearmedical, Inc. | 2005-07-11 |
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Every clearance here is in the API, with alerts when new ones post.