Not Cleared Post-NSE

DEN090011 - HEM-AVERT PERIANAL STABILIZER (FDA 510(k) Clearance)

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

DEN090011 · Plexus Biomedical, Inc. · Obstetrics & Gynecology device
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Jan 2011
Decision
513d
Days
Class 2
Risk

DEN090011 is an FDA 510(k) submission (not cleared) for the HEM-AVERT PERIANAL STABILIZER. Classified as Hemorrhoid Prevention Pressure Wedge (product code OOA), Class II - Special Controls.

Submitted by Plexus Biomedical, Inc. (Oakland, US). The FDA issued a Not Cleared (DENG) decision on January 13, 2011 after a review of 513 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5200 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 513 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Plexus Biomedical, Inc. devices

Submission Details

510(k) Number DEN090011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 18, 2009
Decision Date January 13, 2011
Days to Decision 513 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 160d · This submission: 513d
Pathway characteristics

Device Classification

Product Code OOA Hemorrhoid Prevention Pressure Wedge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5200
Definition Provides A Counter-pressure To The Anus During Vaginal Delivery. Intended To Prevent The Occurrence Of And/or Stop The Progression Of Hemorrhoids Associated With Vaginal Delivery.
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.