NLL — Staple, Implantable, Reprocessed Class II
FDA product code NLL covers "Staple, Implantable, Reprocessed", a Class II medical device regulated under 21 CFR 878.4750. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NLL
- Device Class
- Class II
- Regulation Number
- 878.4750
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070930 | sterilmed | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS | October 18, 2007 |
| K070859 | sterilmed | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS | September 12, 2007 |
| K033578 | clearmedical | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | July 11, 2005 |