The following data is part of a premarket notification filed by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. with the FDA for Video Endoscopy System, 3d Video Endoscopy System.
| Device ID | K210116 |
| 510k Number | K210116 |
| Device Name: | Video Endoscopy System, 3D Video Endoscopy System |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict Cixi, CN 315300 |
| Contact | Ma Guofang |
| 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 | HET |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCJ |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-10-13 |