Panpac Disposable Pessary Fitting Set— 510(k) K153422

Name: FDA 510(k) clearance K153422
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

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. 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: 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 ↗

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More clearances from Panpac Medical Corporation

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K173351 — Panpac Flexi Shelf Pessary2018-10-31
K161106 — PANPAC DISPOSABLE VACUUM CURETTES2017-01-13
K132670 — PANPAC INFLATABLE DOCUT PESSARY2014-06-04
K130087 — PANPAC WORD/BARTHOLIN CATHETER2014-01-10
K130273 — PANPAC VAGINAL DILATORS2013-08-08

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.