K902170 is an FDA 510(k) clearance for the SOEHENDRA LITHOTRIPSY SET. 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 July 25, 1990, 72 days after receiving the submission on May 14, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.
| 510(k) Number | K902170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1990 |
| Decision Date | July 25, 1990 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LQC — Lithotriptor, Biliary Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4500 |