MODIFICATION TO URESTA PESSARY— 510(k) K083769

Substantially Equivalent

Eastmed, Inc.

FDA 510(k) clearance K083769 for MODIFICATION TO URESTA PESSARY, Substantially Equivalent on 2009-01-14. Applicant: Eastmed, Inc..

Clearance details

Applicant: Eastmed, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2008-12-18
Decision date: 2009-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Dundas, 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.