510(k) K150692
K150692 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "AXIOS Stent with Electrocautery Enhanced Delivery System". The FDA issued a decision of Substantially Equivalent on August 5, 2015. The device falls under product code PCU (Pancreatic Stent, Covered, Metallic, Removable), a Class II device regulated under 21 CFR 876.5015. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2015
- Date Received
- March 18, 2015
- Clearance Type
- Traditional
- 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