PANPAC VAGINAL DILATORS— 510(k) K130273

Name: FDA 510(k) clearance K130273
Creator: U.S. Food and Drug Administration
Published: 2013-08-08

Substantially Equivalent

Panpac Medical Corporation

FDA 510(k) clearance K130273 for PANPAC VAGINAL DILATORS, Substantially Equivalent on 2013-08-08. Applicant: Panpac Medical Corporation. Device class: 2.

Clearance details

Applicant: Panpac Medical Corporation
Product code: Code HDX
Device class: Class 2
Regulation: 21 CFR 884.3900
Advisory panel: Obstetrics/Gynecology
Date received: 2013-02-04
Decision date: 2013-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shi-Chib District, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HDX

product code HDX

Other: 1
Total: 1

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.