510(k) K081956
K081956 is an FDA 510(k) premarket notification submitted by Medinol, Ltd. for the device "MEDINOL X-SUIT NIR BILIARY METALLIC STENT". The FDA issued a decision of Substantially Equivalent - With Limitations on Jan 9, 2009. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Medinol, Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU (Substantially Equivalent - With Limitations)
- Decision Date
- Jan 9, 2009
- Date Received
- Jul 9, 2008
- 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
- 510(k)