meddevicedb.com FDA Device Reference

Hem-Avert Perianal Stabilizer

DEN160005 Class II Direct
Decision Date
2016-12-19
Sponsor / Applicant
Stetrix, Inc.

Technical Specification

510(k) Submission ID DEN160005
Product Code PNU
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5210
Decision Date 2016-12-19
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Hem-Avert Perianal Stabilizer received FDA 510(k) clearance under submission number DEN160005, sponsored by Stetrix, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-12-19.

Classification & Regulation

This clearance is catalogued under FDA product code PNU and 21 CFR 884.5210, within the Obstetrics/Gynecology review panel as a Class II device.