FDA 510(k)

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

Número K: K241532 · 2024-10-22

RequerenteShanghai SeeGen Photoelectric Technology Co., Ltd.

Data da decisão2024-10-22

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) 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 2024-10-22 under 510(k) number K241532. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K241532.

When did Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) received FDA 510(k) clearance on 2024-10-22, under 510(k) number K241532.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

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-Choledo-Cysto-Ureteroscope System (PL-2100)?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is FET.

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Outros registros que listam Shanghai SeeGen Photoelectric Technology Co., Ltd. como candidato(a)

K252457Disposable Distal End Tape Hood K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System K211686Flexible Video-Choledo-Cysto-Ureteroscope System

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Fonte oficial

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