Panpac Disposable Pessary Fitting Set— 510(k) K153422

Substantially Equivalent

Panpac Medical Corporation

FDA 510(k) clearance K153422 for Panpac Disposable Pessary Fitting Set, Substantially Equivalent on 2016-07-14. Applicant: Panpac Medical Corporation.

Clearance details

Applicant: Panpac Medical Corporation
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2015-11-25
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Shi-Chih Dist., TW

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.