Clearance Summary
Raney Clips Kit received FDA 510(k) clearance under submission number K253814, sponsored by Beijing Honghugaoxiang Science and Technology Development CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-07-21.
- Submission: K253814
- Applicant / Sponsor: Beijing Honghugaoxiang Science and Technology Development CO
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4150
- Decision date: 2026-07-21
Classification & Regulation
This clearance is catalogued under FDA product code HBO and 21 CFR 882.4150, within the Neurology review panel as a Class II device.