Clearance Summary
SPOT ENDOSCOPIC MARKER received FDA 510(k) clearance under submission number K993951, sponsored by Chek-Med Systems. 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 2000-02-18.
- Submission: K993951
- Applicant / Sponsor: Chek-Med Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-02-18
Classification & Regulation
This clearance is catalogued under FDA product code NBG and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.