MENTOR EVACARE VAGINAL PESSARIES— 510(k) K993308

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K993308 for MENTOR EVACARE VAGINAL PESSARIES, Substantially Equivalent on 1999-12-13. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 1999-10-04
Decision date: 1999-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

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.