510(k) K170833
K170833 is an FDA 510(k) premarket notification submitted by Crospon, Ltd. for the device "EndoFLIP® System with FLIP Topography module". The FDA issued a decision of Substantially Equivalent on April 17, 2017. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Crospon, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2017
- Date Received
- March 20, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type