510(k) K150558
K150558 is an FDA 510(k) premarket notification submitted by Pelvalon, Inc. for the device "Eclipse System". The FDA issued a decision of Substantially Equivalent on November 12, 2015. The device falls under product code PJH (Dynamic Rectal Control System), a Class II device regulated under 21 CFR 876.5930. Pelvalon, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2015
- Date Received
- March 4, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- 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.