Clearance Summary
Button Loop received FDA 510(k) clearance under submission number K202291, sponsored by Yunyi (Beijing) Medical Device Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-01-08.
- Submission: K202291
- Applicant / Sponsor: Yunyi (Beijing) Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2021-01-08
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.