MENTOR CORPORAL DILATORS— 510(k) K860517

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K860517 for MENTOR CORPORAL DILATORS, Substantially Equivalent on 1986-03-11. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code FAE
Advisory panel: Gastroenterology, Urology
Date received: 1986-02-11
Decision date: 1986-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAE

product code FAE

Injury: 995
Total: 995

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.