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U.S. Department of Health and Human Services

Product Classification

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Device hemorrhoid prevention pressure wedge
Regulation Description Hemorrhoid prevention pressure wedge.
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.
Physical State Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks
Technical Method Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery
Target Area anus, hemorrhoids
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOOA
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(K) Exempt
Regulation Number 884.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Third Party Review Not Third Party Eligible
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