TIPI OTC— 510(k) K131198

Substantially Equivalent

Contipi , Ltd.

FDA 510(k) clearance K131198 for TIPI OTC, Substantially Equivalent on 2013-08-27. Applicant: Contipi , Ltd..

Clearance details

Applicant: Contipi , Ltd.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2013-04-26
Decision date: 2013-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.