510(k) DEN090011
DEN090011 is an FDA 510(k) premarket notification submitted by Plexus Biomedical, Inc. for the device "HEM-AVERT PERIANAL STABILIZER". The FDA issued a decision of De Novo Granted on January 13, 2011. The device falls under product code OOA (Hemorrhoid Prevention Pressure Wedge), a Class II device regulated under 21 CFR 884.5200.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 13, 2011
- Date Received
- August 18, 2009
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemorrhoid Prevention Pressure Wedge
- Device Class
- Class II
- Regulation Number
- 884.5200
- Review Panel
- OB
- Submission Type
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.