K212822 is an FDA 510(k) clearance for the Disposable Coaxial Biopsy Needle. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Suzhou Leapmed Healthcare Corporation (Suzhou, CN). The FDA issued a Cleared decision on July 6, 2022, 306 days after receiving the submission on September 3, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K212822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2021 |
| Decision Date | July 06, 2022 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FCG - Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |