K213683 is an FDA 510(k) clearance for the Promisemed Fine Biopsy Needle. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on April 22, 2022, 151 days after receiving the submission on November 22, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K213683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2021 |
| Decision Date | April 22, 2022 |
| Days to Decision | 151 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 |