DeviceClearance

Product code OOA— Obstetrics/Gynecology

HEM-AVERT PERIANAL STABILIZER

Classification name
Hemorrhoid Prevention Pressure Wedge
Device class
Class 2
Regulation
21 CFR 884.5200
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OOA under 21 CFR 884.5200, via openFDA

Market context for product code OOA

FDA has cleared 1 device under product code OOA, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OOA

Recent clearances under product code OOA

Data sourced from openFDA. This site is unofficial and independent of the FDA.