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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: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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