The following data is part of a premarket notification filed by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. with the FDA for Ultrasonic Scalpel System.
| Device ID | K212614 |
| 510k Number | K212614 |
| Device Name: | Ultrasonic Scalpel System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi, CN 315301 |
| Contact | Guofang Ma |
| Correspondent | Guofang Ma Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi, CN 315301 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972304752828 | K212614 | 000 |
| 16972304750480 | K212614 | 000 |
| 16972304750473 | K212614 | 000 |
| 16972304750466 | K212614 | 000 |
| 16972304750459 | K212614 | 000 |
| 16972304750329 | K212614 | 000 |
| 06972304750315 | K212614 | 000 |