K250032 is an FDA 510(k) clearance for the Marquee™ Disposable Core Biopsy Instrument and Instrument Kit. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on July 10, 2025, 184 days after receiving the submission on January 7, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K250032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2025 |
| Decision Date | July 10, 2025 |
| Days to Decision | 184 days |
| Submission Type | Special |
| 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 |