The following data is part of a premarket notification filed by Guangzhou Shengwei Medical Devices Co., Ltd with the FDA for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle.
| Device ID | K214063 |
| 510k Number | K214063 |
| Device Name: | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle |
| Classification | Instrument, Biopsy |
| Applicant | Guangzhou Shengwei Medical Devices Co., Ltd No. 126, Guangshao Road, Aotou Town Conghua City, CN 510900 |
| Contact | Xiaojun Cai |
| Correspondent | Xiaojun Cai Guangzhou Shengwei Medical Devices Co., Ltd No. 126, Guangshao Road, Aotou Town Conghua City, CN 510900 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-06-03 |