FDA 510(k)

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）

K 號：K243535 · 2025-03-07

申請人Shanghai SeeGen Photoelectric Technology Co., Ltd.

決定日期2025-03-07

產品代碼FBN

諮詢委員會GU

決定相當於

器材摘要

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243535. 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 Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K243535.

When did Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) receive FDA 510(k) clearance?

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243535.

Who is the listed applicant for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

The FDA product code for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is FBN.

其他以 Shanghai SeeGen Photoelectric Technology Co., Ltd. 為申請人之記錄

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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。

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官方來源

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