K132612 is an FDA 510(k) clearance for the HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on October 17, 2013, 57 days after receiving the submission on August 21, 2013.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K132612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2013 |
| Decision Date | October 17, 2013 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |