K171989 is an FDA 510(k) clearance for the Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter. This device is classified as a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II - Special Controls, product code ODD).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 20, 2018, 260 days after receiving the submission on July 3, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Identify Stones, Tumors, Or Narrowing In The Biliary Tree..
| 510(k) Number | K171989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2017 |
| Decision Date | March 20, 2018 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODD — Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Identify Stones, Tumors, Or Narrowing In The Biliary Tree. |