PESSARY— 510(k) K132313

Substantially Equivalent

Eis Corporation

FDA 510(k) clearance K132313 for PESSARY, Substantially Equivalent on 2014-12-05. Applicant: Eis Corporation.

Clearance details

Applicant: Eis Corporation
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2013-07-25
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangnam-Gu, KR

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.