MENTOR PERCUTANEOUS RENAL DILATOR SET— 510(k) K850355

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K850355 for MENTOR PERCUTANEOUS RENAL DILATOR SET, Substantially Equivalent on 1985-03-12. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1985-01-30
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, 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.