K181488 is an FDA 510(k) clearance for the LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on October 30, 2018, 146 days after receiving the submission on June 6, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K181488 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2018 |
| Decision Date | October 30, 2018 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |