MTI ST#1 SILICONE PESSARY— 510(k) K020512

Substantially Equivalent

Medical Technology and Innovations, Inc.

FDA 510(k) clearance K020512 for MTI ST#1 SILICONE PESSARY, Substantially Equivalent on 2002-05-16. Applicant: Medical Technology and Innovations, Inc..

Clearance details

Applicant: Medical Technology and Innovations, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2002-02-15
Decision date: 2002-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lee'S Summit, MO, 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.