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FDA 510(k)

PA3X可拆卸安全套筒注射器（带针）（SC-23ED / SD-23ED）

K号: K252098 · 2026-02-18

申请人Methyl Co., Ltd.
决定日期2026-02-18
产品代码MEG
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is the device name listed in this FDA 510(k) record. The listed applicant is Methyl Co., Ltd.. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K252098. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Methyl Co., Ltd.. The 510(k) number is K252098.

When did PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) receive FDA 510(k) clearance?

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

Who is the listed applicant for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

The FDA 510(k) record lists Methyl Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：MEG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250847蒸汽盾Vault Paragon Group, Inc.K230287SaviSafe 安全设备Suzhou Savicred Biotechnology Co., Ltd.K231165Shina 注射器; Shina 安全注射器Shina Med CorporationK231907Medline 安全胰岛素和TB注射器Medline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLCK220114PowerPAK 注射器Vault Paragon Group, Inc.

官方来源

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