Gynethotics Pessary— 510(k) K231786

Substantially Equivalent

Cosm Medical

FDA 510(k) clearance K231786 for Gynethotics Pessary, Substantially Equivalent on 2024-03-06. Applicant: Cosm Medical.

Clearance details

Applicant: Cosm Medical
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2023-06-20
Decision date: 2024-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

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.