FDA 510(k)

單次使用視覺胰膽管內視鏡，PB數位控制器

K 號：K221784 · 2023-02-16

決定日期2023-02-16

產品代碼FBN

諮詢委員會GU

決定相當於

器材摘要

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K221784. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K221784.

When did Single-use Video Pancreaticobiliary Scope, PB Digital Controller receive FDA 510(k) clearance?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller received FDA 510(k) clearance on 2023-02-16, under 510(k) number K221784.

Who is the listed applicant for Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

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

What is the FDA product code for Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

The FDA product code for Single-use Video Pancreaticobiliary Scope, PB Digital Controller is FBN.

其他以 Micro-Tech (Nanjing) 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。

K252492視覺化進入與輸送導管；PB數位控制器 K251692先進組織切除設備 K250229雙動力組織閉合設備 K243388一次性遠端帽 K243471抽獲籃 K230127膽管塑料支架、膽管塑料支架導入器、膽管塑料支架組、膽管塑料支架導入器/短針相容、膽管塑料支架組/短針相容

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相關器械（代碼：FBN）

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。

K254153單次使用視頻內鏡；PB數位控制器Mirco-Tech (Nanjing) Co., Ltd.K253139一次性遠端帽Mirco-Tech (Nanjing) Co., Ltd.K251338肝管內視鏡視覺化系統（一次性視覺肝管內視鏡：SCV-P-01G，SCV-P-02G；全高清內視鏡影像處理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）Scivita Medical Technology Co., Ltd.K251170Tangent單次使用數位系統：Tangent單次使用數位心导管及Tangent數位控制器Tangent Endoscopy, LLC K243535靈活式內視鏡總管內視鏡（CHV-110J-U）；靈活式內視鏡總管內視鏡（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444肝膽胰管內視鏡系統Shenzhen HugeMed Medical Technical Development Co., Ltd.

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