Disposable Sterile Needle
K-Number: K172938 · 2018-06-14
ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2018-06-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Sterile Needle is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2018-06-14 under approval number K172938. 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 Disposable Sterile Needle?
Disposable Sterile Needle is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K172938.
When was Disposable Sterile Needle approved by the FDA?
Disposable Sterile Needle received FDA 510(k) clearance on 2018-06-14, under approval number K172938.
What company makes Disposable Sterile Needle?
Disposable Sterile Needle is manufactured by Jiangsu Caina Medical Co.,Ltd.
What is the FDA product code for Disposable Sterile Needle?
The FDA product code for Disposable Sterile Needle is FMI.
Related Clinical Trials
Related PubMed Literature
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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
K193526Syringe with safety needle, Safety needle
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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.