FDA 510(k)

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01

Número K: K261880 · 2026-07-02

Data da decisão2026-07-02

Código do produtoFET

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261880. 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 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Fujifilm Corporation. The 510(k) number is K261880.

When did FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 receive FDA 510(k) clearance?

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261880.

Who is the listed applicant for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01?

The FDA product code for FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 is FET.

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Outros registros que listam Fujifilm Corporation como candidato(a)

K261229SCENARIA View Phase 6.0 K261283APERTO Lucent MRI System K253836FCT iStream Phase 2 K261170BA-004CC K260567EW10-EC02 Endoscopy Support Program K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

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Fonte oficial

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