Cleared Special

K153422 - Panpac Disposable Pessary Fitting Set

K153422 is an FDA 510(k) clearance for Panpac Disposable Pessary Fitting Set, manufactured by Panpac Medical Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Special 510(k) pathway after a 232-day FDA review.

K153422 · Panpac Medical Corporation · Obstetrics & Gynecology device
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Jul 2016
Decision
232d
Days
Class 2
Risk

K153422 is an FDA 510(k) clearance for the Panpac Disposable Pessary Fitting Set. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Panpac Medical Corporation (Shi-Chih Dist., TW). The FDA issued a Cleared decision on July 14, 2016 after a review of 232 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K153422

510(k) Number K153422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date July 14, 2016
Days to Decision 232 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 161d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

HHW Device Classification - Class 2, Special Controls

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHW Pessary, Vaginal

All 40
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K153422.
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K153422 · Panpac Disposable Pessary Fitting Set
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