K051950 is an FDA 510(k) clearance for the INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 7, 2005, 81 days after receiving the submission on July 18, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K051950 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 18, 2005 |
| Decision Date | October 07, 2005 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MND — Ligator, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |