K111195 is an FDA 510(k) clearance for the VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS, 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 August 3, 2011, 97 days after receiving the submission on April 28, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K111195 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 28, 2011 |
| Decision Date | August 03, 2011 |
| Days to Decision | 97 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 |