Cleared Traditional

Verifine Safety Type Insulin Pen Needle

K210065 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Apr 2021
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K210065 is an FDA 510(k) clearance for the Verifine Safety Type Insulin Pen Needle, 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 April 22, 2021, 101 days after receiving the submission on January 11, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K210065 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2021
Decision Date April 22, 2021
Days to Decision 101 days
Submission Type Traditional
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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