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FDA 510(k)

Insulin syringe with integrated needle DL

K-Number: K203211 · 2023-02-09

ApplicantDlp Medical Products, Corp.
Decision Date2023-02-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin syringe with integrated needle DL is a medical device manufactured by Dlp Medical Products, Corp.. It received FDA 510(k) clearance on 2023-02-09 under approval number K203211. 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 syringe with integrated needle DL?

Insulin syringe with integrated needle DL is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Dlp Medical Products, Corp.. The 510(k) number is K203211.

When was Insulin syringe with integrated needle DL approved by the FDA?

Insulin syringe with integrated needle DL received FDA 510(k) clearance on 2023-02-09, under approval number K203211.

What company makes Insulin syringe with integrated needle DL?

Insulin syringe with integrated needle DL is manufactured by Dlp Medical Products, Corp..

What is the FDA product code for Insulin syringe with integrated needle DL?

The FDA product code for Insulin syringe with integrated needle DL is FMF.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED NCT03186300 Patient Empowerment Through Predictive Personalised Decision Support (PEPPER) COMPLETED NCT07498621 Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction COMPLETED

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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