K864102 is an FDA 510(k) clearance for the LIGACLIP 20/20* MULTIPLE CLIP APPLIER. 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 November 5, 1986, 15 days after receiving the submission on October 21, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K864102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1986 |
| Decision Date | November 05, 1986 |
| Days to Decision | 15 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 |