Cleared Traditional

Disposable Insulin Pen Needle

K221178 · Ningbo Medsun Medical Co., Ltd. · General Hospital

Nov 2022

Decision

206d

Days

Class 2

Risk

About This 510(k) Submission

K221178 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 Ningbo Medsun Medical Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on November 17, 2022, 206 days after receiving the submission on April 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K221178 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2022
Decision Date	November 17, 2022
Days to Decision	206 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF