Clearance Summary
HAND MIRROR (ENDOSCOPE) received FDA 510(k) clearance under submission number K862717, sponsored by Simpson/Basye, 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 1986-07-30.
- Submission: K862717
- Applicant / Sponsor: Simpson/Basye, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1986-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GCO and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.