Cleared Special

Verifine? Pen Needles

K242632 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Sep 2024
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K242632 is an FDA 510(k) clearance for the Verifine? Pen Needles, 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 September 26, 2024, 23 days after receiving the submission on September 3, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K242632 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2024
Decision Date September 26, 2024
Days to Decision 23 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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