K072203 is an FDA 510(k) clearance for the HARMONIC 10CM COMBINATION HOOK BLADE. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on September 25, 2007, 48 days after receiving the submission on August 8, 2007.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K072203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2007 |
| Decision Date | September 25, 2007 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |