Cleared Special

Safety Winged Blood Collection Sets

K243806 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Jan 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243806 is an FDA 510(k) clearance for the Safety Winged Blood Collection Sets, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on January 10, 2025, 30 days after receiving the submission on December 11, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K243806 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2024
Decision Date January 10, 2025
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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