Cleared Traditional

Pen Needle

K230635 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Jun 2023
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K230635 is an FDA 510(k) clearance for the 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 June 2, 2023, 87 days after receiving the submission on March 7, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K230635 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2023
Decision Date June 02, 2023
Days to Decision 87 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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