K063677 is an FDA 510(k) clearance for the FUSION QUATTRO EXTRACTION BALLOON XL. This device is classified as a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II - Special Controls, product code GCA).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 5, 2007, 25 days after receiving the submission on December 11, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K063677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2006 |
| Decision Date | January 05, 2007 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCA — Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |