Clearance Summary
Qlicksmart BladeFlask UNIVERSAL received FDA 510(k) clearance under submission number K213274, sponsored by Qlicksmart Pty , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-06-22.
- Submission: K213274
- Applicant / Sponsor: Qlicksmart Pty , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2022-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.