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FDA 510(k)

Insulin Syringes without needle

K-Number: K221045 · 2022-11-03

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-11-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Syringes without needle is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-03 under approval number K221045. 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 Insulin Syringes without needle?

Insulin Syringes without needle is a medical device that received FDA 510(k) clearance on 2022-11-03. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K221045.

When was Insulin Syringes without needle approved by the FDA?

Insulin Syringes without needle received FDA 510(k) clearance on 2022-11-03, under approval number K221045.

What company makes Insulin Syringes without needle?

Insulin Syringes without needle is manufactured by Berpu Medical Technology Co., Ltd..

What is the FDA product code for Insulin Syringes without needle?

The FDA product code for Insulin Syringes without needle is FMF.

Related Clinical Trials

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Related PubMed Literature

PMID: 40406499 Insulin rationing in states with and without insulin copay caps: a cross-sectional study. Health affairs scholar (2025)

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 K181447Safety insulin needle for single use K220061Safety Insulin Syringes K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use

View all 9 devices →

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. 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.

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.

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