K090485 is an FDA 510(k) clearance for the COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003. This device is classified as a Dislodger, Stone, Biliary (Class II - Special Controls, product code LQR).
Submitted by Percutaneous Systems, Incorporated (Palo Alto, US). The FDA issued a Cleared decision on July 22, 2009, 147 days after receiving the submission on February 25, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K090485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2009 |
| Decision Date | July 22, 2009 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |