OVER THE GUIDEWIRE DILATATION SYSTEM— 510(k) K924646

Substantially Equivalent

Medovations, Inc.

FDA 510(k) clearance K924646 for OVER THE GUIDEWIRE DILATATION SYSTEM, Substantially Equivalent on 1994-12-05. Applicant: Medovations, Inc..

Clearance details

Applicant: Medovations, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1992-09-14
Decision date: 1994-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, WI, US

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Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.