meddevicedb.com FDA Device Reference

HEM-AVERT PERIANAL STABILIZER

DEN090011 Class II Post-NSE
Decision Date
2011-01-13
Sponsor / Applicant
Plexus Biomedical, Inc.

Technical Specification

510(k) Submission ID DEN090011
Product Code OOA
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5200
Decision Date 2011-01-13
Clearance Pathway Post-NSE

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 DEN090011, sponsored by Plexus Biomedical, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-01-13.

Classification & Regulation

This clearance is catalogued under FDA product code OOA and 21 CFR 884.5200, within the Obstetrics/Gynecology review panel as a Class II device.