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FDA 510(k)

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

K-Number: K212033 · 2022-08-17

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2022-08-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is a medical device manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2022-08-17 under approval number K212033. 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 Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K212033.

When was Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle approved by the FDA?

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle received FDA 510(k) clearance on 2022-08-17, under approval number K212033.

What company makes Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd..

What is the FDA product code for Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

The FDA product code for Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is FMF.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40406499 Insulin rationing in states with and without insulin copay caps: a cross-sectional study. Health affairs scholar (2025)

Other Devices by Shandong Zhushi Pharmaceutical Group Co., Ltd.

K210510Disposable Surgical Gown K210643Disposable Surgical Face Mask K210409Disposable Surgical Face Mask K203454Infrared Thermometer K203436Disposable Nitrile Examination Gloves K203439Disposable Vinyl Examination Gloves

View all 8 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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