Clearance Summary
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 received FDA 510(k) clearance under submission number K020824, sponsored by Boston Scientific Corp. 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 2002-04-12.
- Submission: K020824
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2002-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FHN and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.