Cleared Abbreviated

K173351 - Panpac Flexi Shelf Pessary (FDA 510(k) Clearance)

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

K173351 · Panpac Medical Corporation · Obstetrics & Gynecology device
Oct 2018
Decision
371d
Days
Class 2
Risk

K173351 is an FDA 510(k) clearance for the Panpac Flexi Shelf Pessary. 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 October 31, 2018 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K173351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2017
Decision Date October 31, 2018
Days to Decision 371 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 158d · This submission: 371d
Pathway characteristics
Standards-based clearance path.

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.