Clearance Summary
ASK System received FDA 510(k) clearance under submission number K181146, sponsored by L and K Biomed Corporation Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-08-03.
- Submission: K181146
- Applicant / Sponsor: L and K Biomed Corporation Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2018-08-03
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.