Clearance Summary
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR received FDA 510(k) clearance under submission number K192164, sponsored by Olympus Medical Systems Corp.. 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 2020-03-06.
- Submission: K192164
- Applicant / Sponsor: Olympus Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2020-03-06
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.