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

Hemorrhoid Prevention Pressure Wedge

21 CFR 884.5200 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OOA is the FDA product code for Hemorrhoid Prevention Pressure Wedge, a class II device type, regulated under 21 CFR 884.5200. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OOA
Device name
Hemorrhoid Prevention Pressure Wedge
FDA 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.
Regulation
21 CFR 884.5200
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OOA

By decision year
1 clearance under product code OOA with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OOA by decision year
YearClearances
20111

Applicants with the most clearances

Product code OOA
Applicants holding the most 510(k) clearances under product code OOA
ApplicantClearances
Plexus Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code