Pen Needle
K-Number: K230635 · 2023-06-02
ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2023-06-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Pen Needle is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2023-06-02 under approval number K230635. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pen Needle?
Pen Needle is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K230635.
When was Pen Needle approved by the FDA?
Pen Needle received FDA 510(k) clearance on 2023-06-02, under approval number K230635.
What company makes Pen Needle?
Pen Needle is manufactured by Jiangsu Caina Medical Co.,Ltd.
What is the FDA product code for Pen Needle?
The FDA product code for Pen Needle is FMI.
Other Devices by Jiangsu Caina Medical Co.,Ltd
K181374NRFit Syringe
K172938Disposable Sterile Needle
K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
K190502ENFit Oral / Enteral Syringe
K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
K193022Retractable Safety Insulin Syringe
Related Devices (Code: FMI)
K162516BD Pen NeedleBecton, Dickinson and Company
K160532Greiner HoldexGreiner Bio-One Na, Inc.
K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.
K151090CPL Insulin Pen NeedleCpl Co., Ltd.
K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.
K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.