Hemorrhoid Prevention Pressure Wedge
The Hemorrhoid Prevention Pressure Wedge (product code OOA) is a Class 1 device regulated under 21 CFR 884.5200 in the Obstetrics/Gynecology specialty (OB), exempt from premarket notification. It provides counter-pressure to the anus during vaginal delivery and is intended to prevent the occurrence of or stop the progression of hemorrhoids associated with the delivery process. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OOA
- Device Class
- FDA class 2
- Regulation Number
- 884.5200
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN090011 | HEM-AVERT PERIANAL STABILIZER | Jan 13, 2011 | Unknown | Plexus Biomedical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.