K220611 is an FDA 510(k) clearance for the SUREcore Plus Biopsy Instrument. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Uro-1, Inc. (Greensboro, US). The FDA issued a Cleared decision on December 2, 2022, 274 days after receiving the submission on March 3, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K220611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2022 |
| Decision Date | December 02, 2022 |
| Days to Decision | 274 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 |