K193344 is an FDA 510(k) clearance for the Tri-Ex Extraction Balloon with Multiple Sizing, 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. (Winstrom-Salem, US). The FDA issued a Cleared decision on December 13, 2019, 10 days after receiving the submission on December 3, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K193344 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 10 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 |