Clearance Summary
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) received FDA 510(k) clearance under submission number K251731, sponsored by Karl Storz SE & CO. KG. 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 2025-12-05.
- Submission: K251731
- Applicant / Sponsor: Karl Storz SE & CO. KG
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2025-12-05
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.