Safety insulin needle for single use
K-Number: K181447 · 2019-03-12
ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2019-03-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Safety insulin needle for single use is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-03-12 under approval number K181447. 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 Safety insulin needle for single use?
Safety insulin needle for single use is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K181447.
When was Safety insulin needle for single use approved by the FDA?
Safety insulin needle for single use received FDA 510(k) clearance on 2019-03-12, under approval number K181447.
What company makes Safety insulin needle for single use?
Safety insulin needle for single use is manufactured by Berpu Medical Technology Co., Ltd..
What is the FDA product code for Safety insulin needle for single use?
The FDA product code for Safety insulin needle for single use is FMI.
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Other Devices by Berpu Medical Technology Co., Ltd.
K162180Disposable Insulin Syringe
K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
K221045Insulin Syringes without needle
K220061Safety Insulin Syringes
K213158Syringe with permanently attached needle
K213811Sterile Hypodermic Syringes for Single Use
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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.