K222865 is an FDA 510(k) clearance for the M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Canyon Medical, Inc. (Nanjing, CN). The FDA issued a Cleared decision on April 3, 2023, 193 days after receiving the submission on September 22, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K222865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2022 |
| Decision Date | April 03, 2023 |
| Days to Decision | 193 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 |