# Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge
> **Food and Drug Administration** · Final rule. · Published 2011-04-15 · Effective 2011-05-16 · 76 FR 21237
## Document
- **Document number:** 2011-9141
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 21237
- **CFR reference:** 21 CFR 884
- **Publication date:** 2011-04-15
- **Effective date:** 2011-05-16
- **HHS docket:** Docket No. FDA-2011-N-0118
## Abstract

The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/04/15/2011-9141/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-hemorrhoid-prevention)
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