Cleared Special

K153422 - Panpac Disposable Pessary Fitting Set (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K153422 · Panpac Medical Corporation · Obstetrics & Gynecology device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 158d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.