510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN090011Unknown

Hem-Avert Perianal Stabilizer

Plexus Biomedical, Inc., Oakland TN / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN090011 is the FDA 510(k) clearance record for HEM-AVERT PERIANAL STABILIZER, a class II device, cleared for Plexus Biomedical, Inc. on under FDA product code OOA (Hemorrhoid Prevention Pressure Wedge). FDA's definition for product code OOA reads: "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". FDA records list one 510(k) clearance for Plexus Biomedical, Inc. As of , FDA records show no recalls naming DEN090011.

Clearance record

Decision date
Received
(513 days to decision)
Product code
OOA Hemorrhoid Prevention Pressure Wedge
Regulation
21 CFR 884.5200
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Plexus Biomedical, Inc. 70 Clay St., Oakland TN
Third party review
No

Clearances, product code OOA

Trailing 12 months

FDA records hold no clearances under product code OOA in the trailing twelve months.

FDA records show no clearances under product code OOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OOA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260