K173316 is an FDA 510(k) clearance for the SpeedBird Model SB38 Soft Tissue Biopsy Device. 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 June 19, 2018, 243 days after receiving the submission on October 19, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K173316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2017 |
| Decision Date | June 19, 2018 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |