K811935 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE LIGATING CLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981, 67 days after receiving the submission on July 6, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K811935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1981 |
| Decision Date | September 11, 1981 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |