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FDA 510(k)

Sterile syringes for single use with/without needle

K-Number: K211211 · 2021-10-07

ApplicantAzur Medical Company, Inc.
Decision Date2021-10-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile syringes for single use with/without needle is a medical device manufactured by Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2021-10-07 under approval number K211211. 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 Sterile syringes for single use with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-10-07. It is manufactured by Azur Medical Company, Inc.. The 510(k) number is K211211.

When was Sterile syringes for single use with/without needle approved by the FDA?

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2021-10-07, under approval number K211211.

What company makes Sterile syringes for single use with/without needle?

Sterile syringes for single use with/without needle is manufactured by Azur Medical Company, Inc..

What is the FDA product code for Sterile syringes for single use with/without needle?

The FDA product code for Sterile syringes for single use with/without needle is FMF.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT06888687 Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes. ACTIVE_NOT_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT04605302 Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms COMPLETED

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)

Other Devices by Azur Medical Company, Inc.

K211214Sterile Hypodermic Needles for Single Use K211210Sterile Auto-Disable Syringes with/without Needle for Single Use K231719Medical Surgical Mask

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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