K223300 is an FDA 510(k) clearance for the Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Geotek Medikal Ltd Sti (Ankara, TR). The FDA issued a Cleared decision on April 21, 2023, 176 days after receiving the submission on October 27, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K223300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2022 |
| Decision Date | April 21, 2023 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |