Cleared Traditional

Safety Insulin Pen Needle

K192677 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Feb 2020
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K192677 is an FDA 510(k) clearance for the Safety Insulin Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on February 18, 2020, 145 days after receiving the submission on September 26, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K192677 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2019
Decision Date February 18, 2020
Days to Decision 145 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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