K214063 is an FDA 510(k) clearance for the Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Guangzhou Shengwei Medical Devices Co., Ltd. (Conghua City, CN). The FDA issued a Cleared decision on June 3, 2022, 158 days after receiving the submission on December 27, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K214063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | June 03, 2022 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |