K812291 is an FDA 510(k) clearance for the ETHICON MULTIPLE LIGATING CLIP APPLIER. This device is classified as a Applier, Surgical, Clip (Class I - General Controls, product code GDO).
Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1981, 29 days after receiving the submission on August 13, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K812291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1981 |
| Decision Date | September 11, 1981 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDO — Applier, Surgical, Clip |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |