OOA — Hemorrhoid Prevention Pressure Wedge Class II
FDA product code OOA covers "Hemorrhoid Prevention Pressure Wedge", a Class II medical device regulated under 21 CFR 884.5200. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OOA
- Device Class
- Class II
- Regulation Number
- 884.5200
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN090011 | plexus biomedical | HEM-AVERT PERIANAL STABILIZER | January 13, 2011 |