Cleared Traditional

Disposable Medical Safety Hypodermic Needle

K220603 · Hantech Medical Device Co., Ltd. · General Hospital
Aug 2022
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K220603 is an FDA 510(k) clearance for the Disposable Medical Safety Hypodermic 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 August 23, 2022, 174 days after receiving the submission on March 2, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K220603 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2022
Decision Date August 23, 2022
Days to Decision 174 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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