The following data is part of a premarket notification filed by Jiangsu Vedkang Medical Science And Technology Co.,ltd. with the FDA for Disposable Polyp Snare.
| Device ID | K220089 |
| 510k Number | K220089 |
| Device Name: | Disposable Polyp Snare |
| Classification | Snare, Flexible |
| Applicant | Jiangsu Vedkang Medical Science And Technology Co.,Ltd. No. 52, Guoxiang Road, Wujin Economic Development Zone Changzhou, CN 213149 |
| Contact | Tang Ting |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co.,Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-11 |
| Decision Date | 2022-09-22 |