NLL · Staple, Implantable, Reprocessed
General, Plastic Surgery · 21 CFR 878.4750 · Class 2
Overview
| Product Code | NLL |
|---|---|
| Device Name | Staple, Implantable, Reprocessed |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070930 | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS | Sterilmed, Inc. | Oct 18, 2007 | SESE |
| K070859 | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS | Sterilmed, Inc. | Sep 12, 2007 | SESE |
| K033578 | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | Clearmedical, Inc. | Jul 11, 2005 | SESE |
Top Applicants
- Sterilmed, Inc. — 2 clearances
- Clearmedical, Inc. — 1 clearance
