K011178 is an FDA 510(k) clearance for the WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR. This device is classified as a Lithotriptor, Biliary Mechanical (Class II - Special Controls, product code LQC).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on May 4, 2001, 17 days after receiving the submission on April 17, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.
| 510(k) Number | K011178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2001 |
| Decision Date | May 04, 2001 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQC — Lithotriptor, Biliary Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4500 |