免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

PA3X可拆式安全套筒針筒（含針）（SC-23ED / SD-23ED）

K 號：K252098 · 2026-02-18

申請人Methyl Co., Ltd.
決定日期2026-02-18
產品代碼MEG
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：MEG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250847霧盾Vault Paragon Group, Inc.K230287SaviSafe 安全設備Suzhou Savicred Biotechnology Co., Ltd.K231165信娜針筒；信娜安全針筒Shina Med CorporationK231907美林安全胰島素及結核針筒Medline Industries, LPK223376Monoject Magellan 胰島素安全針筒 1mL, 31G x 6mm (8881893110)；Monoject Magellan 胰島素安全針筒 0.5mL, 31G x 6mm (8881893150)；Monoject Magellan 胰島素安全針筒 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLCK220114PowerPAK 靜脈注射針Vault Paragon Group, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑