Clearance Summary
EGIS Biliary Double Bare Stent (BDB080405) received FDA 510(k) clearance under submission number K242845, sponsored by S&G Biotech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-06-25.
- Submission: K242845
- Applicant / Sponsor: S&G Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2025-06-25
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.