The following data is part of a premarket notification filed by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. with the FDA for Radio Frequency Ablation System.
| Device ID | K190052 |
| 510k Number | K190052 |
| Device Name: | Radio Frequency Ablation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi, CN 315300 |
| 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 315300 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972304750190 | K190052 | 000 |
| 16972304750084 | K190052 | 000 |
| 16972304750077 | K190052 | 000 |
| 16972304750060 | K190052 | 000 |
| 16972304750053 | K190052 | 000 |
| 16972304750046 | K190052 | 000 |
| 16972304750039 | K190052 | 000 |
| 16972304750022 | K190052 | 000 |
| 06972304751411 | K190052 | 000 |
| 16972304750091 | K190052 | 000 |
| 16972304750107 | K190052 | 000 |
| 16972304750183 | K190052 | 000 |
| 16972304750176 | K190052 | 000 |
| 16972304750169 | K190052 | 000 |
| 16972304750152 | K190052 | 000 |
| 16972304750145 | K190052 | 000 |
| 16972304750138 | K190052 | 000 |
| 16972304750121 | K190052 | 000 |
| 16972304750114 | K190052 | 000 |
| 06972304750209 | K190052 | 000 |