The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Automatic Biopsy Needles, Promisemed Co-axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles.
| Device ID | K210946 |
| 510k Number | K210946 |
| Device Name: | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles |
| Classification | Instrument, Biopsy |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, CN 311121 |
| Contact | Zearou Yang |
| Correspondent | Wei Shan Hsu Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CN |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-30 |
| Decision Date | 2021-08-12 |