Clearance Summary
Tech-Image Video Endoscope System received FDA 510(k) clearance under submission number K260414, sponsored by Tech-Image CO., 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 2026-06-10.
- Submission: K260414
- Applicant / Sponsor: Tech-Image CO., LTD.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-06-10
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.