Clearance Summary
EBERLE Shaver System C3 and Accessories received FDA 510(k) clearance under submission number K193608, sponsored by Eberle GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-01-15.
- Submission: K193608
- Applicant / Sponsor: Eberle GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2021-01-15
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.