K191472 is an FDA 510(k) clearance for the Biopsy Needle, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Ushare Medical, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on January 29, 2020, 240 days after receiving the submission on June 3, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K191472 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2019 |
| Decision Date | January 29, 2020 |
| Days to Decision | 240 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 |