Not Cleared Direct

DEN160005 - Hem-Avert Perianal Stabilizer (FDA 510(k) Clearance)

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

DEN160005 · Stetrix, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
326d
Days
Class 2
Risk

DEN160005 is an FDA 510(k) submission (not cleared) for the Hem-Avert Perianal Stabilizer. Classified as Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery (product code PNU), Class II - Special Controls.

Submitted by Stetrix, Inc. (Oakland, US). The FDA issued a Not Cleared (DENG) decision on December 19, 2016 after a review of 326 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5210 - 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 326 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 Stetrix, Inc. devices

Submission Details

510(k) Number DEN160005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 28, 2016
Decision Date December 19, 2016
Days to Decision 326 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 160d · This submission: 326d
Pathway characteristics

Device Classification

Product Code PNU Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5210
Definition Designed To Provide Counter-pressure To The Perianal Region During Vaginal Childbirth To Help Reduce The Likelihood Of Cesarean 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.