K864350 is an FDA 510(k) clearance for the VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 18, 1986, 44 days after receiving the submission on November 4, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K864350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1986 |
| Decision Date | December 18, 1986 |
| Days to Decision | 44 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 |