The following data is part of a premarket notification filed by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. with the FDA for Microwave Ablation System.
| Device ID | K183153 |
| 510k Number | K183153 |
| Device Name: | Microwave Ablation System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Cixi, CN 315300 |
| Contact | Guofang Ma |
| Correspondent | Guofang Ma Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Cixi, CN 315300 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-14 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972304750282 | K183153 | 000 |
| 16972304750275 | K183153 | 000 |
| 16972304750268 | K183153 | 000 |
| 16972304750251 | K183153 | 000 |
| 16972304750244 | K183153 | 000 |
| 16972304750237 | K183153 | 000 |
| 16972304750015 | K183153 | 000 |
| 06972304751435 | K183153 | 000 |
| 06972304750292 | K183153 | 000 |