K913139 is an FDA 510(k) clearance for the IMPLANTABLE METAL STAPLES. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 6, 1991, 52 days after receiving the submission on July 16, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K913139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1991 |
| Decision Date | September 06, 1991 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |