K233031 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 January 17, 2024, 114 days after receiving the submission on September 25, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K233031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | January 17, 2024 |
| Days to Decision | 114 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 |