K212614 is an FDA 510(k) clearance for the Ultrasonic Scalpel System, a Instrument, Ultrasonic Surgical, submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on July 18, 2022, 334 days after receiving the submission on August 18, 2021. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K212614 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 2021 |
| Decision Date | July 18, 2022 |
| Days to Decision | 334 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |