Clearance Summary
Flexible Intubation Video Endoscope Sterile (FIVE-S) received FDA 510(k) clearance under submission number K212656, sponsored by Karl Storz Endoscopy America. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-12-29.
- Submission: K212656
- Applicant / Sponsor: Karl Storz Endoscopy America
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2021-12-29
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.