Cleared Traditional

Disposable Insulin Pen Needle

K222739 · Hantech Medical Device Co., Ltd. · General Hospital
Apr 2023
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K222739 is an FDA 510(k) clearance for the Disposable Insulin Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on April 6, 2023, 209 days after receiving the submission on September 9, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K222739 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2022
Decision Date April 06, 2023
Days to Decision 209 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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