FDA 510(k)

單次使用无菌針筒（含/不含針）

K 號：K210227 · 2021-09-10

申請人Zhejiang Kangkang Medical-Devices Co., Ltd.

決定日期2021-09-10

產品代碼FMF

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

Sterile syringe for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K210227. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile syringe for single use with/without needle?

Sterile syringe for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210227.

When did Sterile syringe for single use with/without needle receive FDA 510(k) clearance?

Sterile syringe for single use with/without needle received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210227.

Who is the listed applicant for Sterile syringe for single use with/without needle?

The FDA 510(k) record lists Zhejiang Kangkang Medical-Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile syringe for single use with/without needle?

The FDA product code for Sterile syringe for single use with/without needle is FMF.

其他以 Zhejiang Kangkang Medical-Devices Co., Ltd. 為申請人之記錄

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。

K213535單次使用无菌安全針頭 K210229无菌單次使用自閉針筒（含/不含針）K210232單次使用无菌皮下針頭

相關器械（代碼：FMF）

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。

K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLC K252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLC K253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., Ltd.

官方來源

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