Cleared Traditional

Disposable Insulin Syringe

K222672 · Hantech Medical Device Co., Ltd. · General Hospital
Mar 2023
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K222672 is an FDA 510(k) clearance for the Disposable Insulin Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on March 6, 2023, 181 days after receiving the submission on September 6, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K222672 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2022
Decision Date March 06, 2023
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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