Clearance Summary
SpyGlass DS and DS II Direct Visualization System received FDA 510(k) clearance under submission number K181439, sponsored by Boston Scientific Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-08-23.
- Submission: K181439
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2018-08-23
Classification & Regulation
This clearance is catalogued under FDA product code FBN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.