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FDA 510(k)

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

Número K: K240276 · 2024-05-10

RequerenteGiven Imaging Ltd. (D.B.A. Medtronic)
Data da decisão2024-05-10
Código do produtoNEZ
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging Ltd. (D.B.A. Medtronic). It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240276. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Given Imaging Ltd. (D.B.A. Medtronic). The 510(k) number is K240276.

When did PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software receive FDA 510(k) clearance?

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240276.

Who is the listed applicant for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

The FDA 510(k) record lists Given Imaging Ltd. (D.B.A. Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

The FDA product code for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is NEZ.

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