510(k) DEN140020
DEN140020 is an FDA 510(k) premarket notification submitted by Pelvalon for the device "ECLIPSE SYSTEM". The FDA issued a decision of De Novo Granted on February 12, 2015. The device falls under product code PJH (Dynamic Rectal Control System), a Class II device regulated under 21 CFR 876.5930. Pelvalon has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 12, 2015
- Date Received
- June 24, 2014
- Clearance Type
- Direct
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Dynamic Rectal Control System
- Device Class
- Class II
- Regulation Number
- 876.5930
- Review Panel
- GU
- Submission Type
Intended to treat fecal incontinence by controlling the size of the rectal lumen.