OOA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemorrhoid Prevention Pressure Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5200
- Medical specialty
- Obstetrics/Gynecology
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| HEM-AVERT PERIANAL STABILIZER (DEN090011) | Plexus Biomedical, Inc. | 2011-01-13 |
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