Clearance Summary
OPTISCAN MODEL OPTISCAN CEIS received FDA 510(k) clearance under submission number K093624, sponsored by Optiscan Pty. , Ltd.. 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 2010-03-05.
- Submission: K093624
- Applicant / Sponsor: Optiscan Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-03-05
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.