510(k) K181669
K181669 is an FDA 510(k) premarket notification submitted by Brightwater Medical for the device "ConvertX Biliary Stent System". The FDA issued a decision of Substantially Equivalent on Mar 14, 2019. 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. Brightwater Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2019
- Date Received
- Jun 25, 2018
- 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)