K153763 is an FDA 510(k) clearance for the Howell Biliary Aspiration Needle. This device is classified as a Instrument, Biopsy, Suction (Class II - Special Controls, product code FCK).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 6, 2017, 463 days after receiving the submission on December 30, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K153763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2015 |
| Decision Date | April 06, 2017 |
| Days to Decision | 463 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCK — Instrument, Biopsy, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |