510(k) K192043
K192043 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AXIOS Stent and Electrocautery Enhanced Delivery System". The FDA issued a decision of Substantially Equivalent on August 26, 2019. The device falls under product code PCU (Pancreatic Stent, Covered, Metallic, Removable), a Class II device regulated under 21 CFR 876.5015. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2019
- Date Received
- July 31, 2019
- 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