K062000 is an FDA 510(k) clearance for the HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH, a Instrument, Ultrasonic Surgical, submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 25, 2006, 70 days after receiving the submission on July 17, 2006. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K062000 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2006 |
| Decision Date | September 25, 2006 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |