510(k) K140561
K140561 is an FDA 510(k) premarket notification submitted by Xlumena, Inc. for the device "AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code PCU (Pancreatic Stent, Covered, Metallic, Removable), a Class II device regulated under 21 CFR 876.5015. Xlumena, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2014
- Date Received
- March 5, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pancreatic Stent, Covered, Metallic, Removable
- Device Class
- Class II
- Regulation Number
- 876.5015
- Review Panel
- GU
- Submission Type
To facilitate transmural endoscopic drainage of pancreatic pseudocysts