PANPAC INFLATABLE DOCUT PESSARY— 510(k) K132670

Name: FDA 510(k) clearance K132670
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Substantially Equivalent

Panpac Medical Corporation

FDA 510(k) clearance K132670 for PANPAC INFLATABLE DOCUT PESSARY, Substantially Equivalent on 2014-06-04. Applicant: Panpac Medical Corporation. Device class: 2.

Clearance details

Applicant: Panpac Medical Corporation
Product code: Code HHW
Device class: Class 2
Regulation: 21 CFR 884.3575
Advisory panel: Obstetrics/Gynecology
Date received: 2013-08-27
Decision date: 2014-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shi-Chih City, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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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.