MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR— 510(k) K943191

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K943191 for MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR, Substantially Equivalent on 1994-08-29. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LQC
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-05
Decision date: 1994-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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Adverse events under product code LQC

product code LQC

Death: 7
Injury: 247
Malfunction: 956
Total: 1,210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.