Clearance Summary
RF Cannula received FDA 510(k) clearance under submission number K241367, sponsored by Shanghai Samedical & Plastic Instruments Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-01-23.
- Submission: K241367
- Applicant / Sponsor: Shanghai Samedical & Plastic Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2025-01-23
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.