Disposable Insulin Syringe
K-Number: K162180 · 2016-12-29
ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2016-12-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Insulin Syringe is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-29 under approval number K162180. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Insulin Syringe?
Disposable Insulin Syringe is a medical device that received FDA 510(k) clearance on 2016-12-29. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K162180.
When was Disposable Insulin Syringe approved by the FDA?
Disposable Insulin Syringe received FDA 510(k) clearance on 2016-12-29, under approval number K162180.
What company makes Disposable Insulin Syringe?
Disposable Insulin Syringe is manufactured by Berpu Medical Technology Co., Ltd..
What is the FDA product code for Disposable Insulin Syringe?
The FDA product code for Disposable Insulin Syringe is FMF.
Related Clinical Trials
Other Devices by Berpu Medical Technology Co., Ltd.
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
K181447Safety insulin needle for single use
K221045Insulin Syringes without needle
K220061Safety Insulin Syringes
K213158Syringe with permanently attached needle
K213811Sterile Hypodermic Syringes for Single Use
Related Devices (Code: FMF)
K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company
K162602NovoPen EchoNovo Nordisk, Inc.
K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.
K152879Sure-Fine Insulin SyringesShina Med Corporation
K160629InPenCompanion Medical, Inc.
K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGESung Shim Medicare Co., Ltd.
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.