ACCENT DG BALLOON URTERAL DILATOR SET, 10CM— 510(k) K915392

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K915392 for ACCENT DG BALLOON URTERAL DILATOR SET, 10CM, Substantially Equivalent on 1992-03-18. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-29
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.