FDA 510(k)

PureWay 尖端容器 1 加侖，2 加侖，3 加侖（800011 800012，800013）

K 號：K251874 · 2025-10-14

決定日期2025-10-14

產品代碼MMK

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

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is the device name listed in this FDA 510(k) record. The listed applicant is Pureway Compliance, Inc.. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K251874. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Pureway Compliance, Inc.. The 510(k) number is K251874.

When did PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) receive FDA 510(k) clearance?

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) received FDA 510(k) clearance on 2025-10-14, under 510(k) number K251874.

Who is the listed applicant for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

The FDA 510(k) record lists Pureway Compliance, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

The FDA product code for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is MMK.

其他以 Pureway Compliance, Inc. 為申請人之記錄

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K231484PureWay 1.4夸脱針具收集器

相關器械（代碼：MMK）

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。

官方來源

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