510(k) K152069
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter by
Navilyst Medical, Inc.
— Product Code FGE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2015
- Date Received
- July 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type