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FDA 510(k)

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

K-Number: K252098 · 2026-02-18

ApplicantMethyl Co., Ltd.
Decision Date2026-02-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is a medical device manufactured by Methyl Co., Ltd.. It received FDA 510(k) clearance on 2026-02-18 under approval number K252098. 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 PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is a medical device that received FDA 510(k) clearance on 2026-02-18. It is manufactured by Methyl Co., Ltd.. The 510(k) number is K252098.

When was PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) approved by the FDA?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) received FDA 510(k) clearance on 2026-02-18, under approval number K252098.

What company makes PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is manufactured by Methyl Co., Ltd..

What is the FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

The FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is MEG.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia 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

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)

Related Devices (Code: MEG)

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. 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.

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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