Clearance Summary
CMOS Video Esophagoscope SSU received FDA 510(k) clearance under submission number K192523, sponsored by Karl Storz SE & CO. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2020-01-24.
- Submission: K192523
- Applicant / Sponsor: Karl Storz SE & CO. KG
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4710
- Decision date: 2020-01-24
Classification & Regulation
This clearance is catalogued under FDA product code EOX and 21 CFR 874.4710, within the Ear, Nose, Throat review panel as a Class II device.