The following data is part of a premarket notification filed by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. with the FDA for Ultrasonic Surgical & Electrosurgical Generator.
| Device ID | K210488 |
| 510k Number | K210488 |
| Device Name: | Ultrasonic Surgical & Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Cixi, CN 315301 |
| Contact | Guofang Ma |
| Correspondent | Guofang Ma Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Cixi, CN 315301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972304750728 | K210488 | 000 |
| 06972304750711 | K210488 | 000 |
| 06972304750704 | K210488 | 000 |
| 06972304750698 | K210488 | 000 |
| 06972304750681 | K210488 | 000 |
| 06972304750667 | K210488 | 000 |