Clearance Summary
Sterile single use tip cleaner (WK800-S10 , WK800-S20) received FDA 510(k) clearance under submission number K241022, sponsored by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-07-11.
- Submission: K241022
- Applicant / Sponsor: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2024-07-11
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.