INSCOPE 3-STAGE BALLOON DILATOR— 510(k) K043605

Substantially Equivalent

Cordis Europa, N.V.

FDA 510(k) clearance K043605 for INSCOPE 3-STAGE BALLOON DILATOR, Substantially Equivalent on 2005-02-04. Applicant: Cordis Europa, N.V..

Clearance details

Applicant: Cordis Europa, N.V.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-30
Decision date: 2005-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roden, Drenthe, NL

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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.