FDA 510(k)

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

N.º K: K243535 · 2025-03-07

SolicitanteShanghai SeeGen Photoelectric Technology Co., Ltd.

Fecha de decisión2025-03-07

Código de productoFBN

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Dispositivos relacionados (Código: FBN)

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Fuente oficial

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