Cleared Abbreviated

Qlicksmart BladeFlask UNIVERSAL

K213274 · Qlicksmart Pty , Ltd. · General Hospital
Jun 2022
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K213274 is an FDA 510(k) clearance for the Qlicksmart BladeFlask UNIVERSAL, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Qlicksmart Pty , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on June 22, 2022, 265 days after receiving the submission on September 30, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K213274 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2021
Decision Date June 22, 2022
Days to Decision 265 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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