K943191 is an FDA 510(k) clearance for the MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR. This device is classified as a Lithotriptor, Biliary Mechanical (Class II - Special Controls, product code LQC).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 29, 1994, 55 days after receiving the submission on July 5, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.
| 510(k) Number | K943191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1994 |
| Decision Date | August 29, 1994 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| 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 |