510(k) K251229
K251229 is an FDA 510(k) premarket notification submitted by Softac Medical Technologies for the device "EndoFixTissue Fixation System". The FDA issued a decision of Substantially Equivalent on August 20, 2025. 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
- August 20, 2025
- Date Received
- April 21, 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