FDA 510(k)

單次使用視頻內鏡；PB數位控制器

K 號：K254153 · 2026-04-03

決定日期2026-04-03

產品代碼FBN

諮詢委員會GU

決定相當於

器材摘要

Single-use Video Scope; PB Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K254153. 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 Scope; PB Digital Controller?

Single-use Video Scope; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K254153.

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

Single-use Video Scope; PB Digital Controller received FDA 510(k) clearance on 2026-04-03, under 510(k) number K254153.

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

The FDA 510(k) record lists Mirco-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 Scope; PB Digital Controller?

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

其他以 Mirco-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。

K260262注射針 K253832擴張氣球心导管 K253139一次性遠端帽 K233772一次性雙動作組織閉合設備

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。

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.K233752龍飛™ 胰膽鏡；龍飛™ 電子控制器；龍飛™ 器材通道蓋CenterPoint Systems, LLC

官方來源

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