K063192 is an FDA 510(k) clearance for the HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on January 30, 2007, 102 days after receiving the submission on October 20, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K063192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2006 |
| Decision Date | January 30, 2007 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |