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FDA 510(k)

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

K-Number: K162030 · 2016-08-19

ApplicantSol-Millennium Medical, Inc.
Decision Date2016-08-19
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is a medical device manufactured by Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2016-08-19 under approval number K162030. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Sol-Millennium Medical, Inc.. The 510(k) number is K162030.

When was 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle approved by the FDA?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle received FDA 510(k) clearance on 2016-08-19, under approval number K162030.

What company makes 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is manufactured by Sol-Millennium Medical, Inc..

What is the FDA product code for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

The FDA product code for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is MEG.

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 NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING 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

Related PubMed Literature

PMID: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) 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 Sol-Millennium Medical, Inc.

K153537Sol-M Insulin Syringe, Sol-M TB Syringe K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set K222744Sol-M Luer Lock Syringe K213718SOL-GUARD Safety Pull Button Collection Set K220713Sol-Guard Auto-disable Syringe

View all 11 devices →

Related Devices (Code: MEG)

K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group , Ltd. K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. 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 UseBerpu Medical Technology Co., Ltd.

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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