K102632 is an FDA 510(k) clearance for the ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 7, 2010, 24 days after receiving the submission on September 13, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K102632 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2010 |
| Decision Date | October 07, 2010 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4750 |