510(k) K253987
K253987 is an FDA 510(k) premarket notification submitted by GIE Medical for the device "BARE Wireguided Balloon Dilation Catheter (1235)". The FDA issued a decision of Substantially Equivalent on March 13, 2026. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2026
- Date Received
- December 12, 2025
- 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