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

Name: FDA 510(k) clearance K020512
Creator: U.S. Food and Drug Administration
Published: 2002-05-16

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.. Device class: 2.

Clearance details

Applicant: Medical Technology and Innovations, Inc.
Product code: Code HHW
Device class: Class 2
Regulation: 21 CFR 884.3575
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 ↗

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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.