OOA · Class II · 21 CFR 884.5200

FDA Product Code OOA: Hemorrhoid Prevention Pressure Wedge

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.

Leading manufacturers include Plexus Biomedical, Inc..

1
Total
0
Cleared
513d
Avg days
2011
Since

FDA 510(k) Cleared Hemorrhoid Prevention Pressure Wedge Devices (Product Code OOA)

1 devices
1–1 of 1
Not Cleared Jan 13, 2011
HEM-AVERT PERIANAL STABILIZER
DEN090011
Plexus Biomedical, Inc.
Obstetrics & Gynecology · 513d

About Product Code OOA - Regulatory Context