Clearance Summary
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 received FDA 510(k) clearance under submission number K912265, sponsored by Medical Laser, 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 1991-10-10.
- Submission: K912265
- Applicant / Sponsor: Medical Laser, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1991-10-10
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.