K151340 is an FDA 510(k) clearance for the HARMONIC Focus Long Shears + Adaptive Tissue Technology. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on July 10, 2015, 52 days after receiving the submission on May 19, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K151340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2015 |
| Decision Date | July 10, 2015 |
| Days to Decision | 52 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |