510(k) K232596
K232596 is an FDA 510(k) premarket notification submitted by Endogi Medical, Ltd. for the device "EndoGI S-Path Biliary Stent System". The FDA issued a decision of SESU on Sep 27, 2023. 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. Endogi Medical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- Sep 27, 2023
- Date Received
- Aug 25, 2023
- Clearance Type
- Special
- 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