Flexible Video-Choledochoscope - Flexible Video-Choledochoscope (CHV-110J-U)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243535

by Shanghai SeeGen Photoelectric Technology Co., Ltd

Identifiers

510(k) Number: K243535 FDA 510(k)
FDA Product Code: FBN FDA 510(k)
Models / Variants: Flexible Video-Choledochoscope (CHV-110J-U) FDA 510(k)
Flexible Video-Choledochoscope (CHV-US120J-U) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Flexible Video-Choledochoscope - Flexible Video-Choledochoscope (CHV-110J-U) by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class II — FDA_510K…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K243535	Class II	Active

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Manufacturer

Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd
FDA Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.

Sources (1)

FDA 510(k) K243535 24 fields · synced Jun 19, 2026