K201244 is an FDA 510(k) clearance for the Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Transmed7, LLC (Portola Valley, US). The FDA issued a Cleared decision on August 7, 2020, 91 days after receiving the submission on May 8, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K201244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2020 |
| Decision Date | August 07, 2020 |
| Days to Decision | 91 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |