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FDA 510(k)

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

K-Number: K213054 · 2022-12-09

ApplicantMedline Industries, Inc.
Decision Date2022-12-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-12-09 under approval number K213054. 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 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-12-09. It is manufactured by Medline Industries, Inc.. The 510(k) number is K213054.

When was Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe approved by the FDA?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe received FDA 510(k) clearance on 2022-12-09, under approval number K213054.

What company makes Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe?

The FDA product code for Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe is FMF.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED 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 NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING

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: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

Other Devices by Medline Industries, Inc.

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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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