Clearance Summary
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED received FDA 510(k) clearance under submission number K060302, sponsored by Cordis Europa, N.V.. 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 2006-04-11.
- Submission: K060302
- Applicant / Sponsor: Cordis Europa, N.V.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 2006-04-11
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.