FDA 510(k)

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Número K: K230991 · 2023-06-30

RequerenteGiven Imaging Ltd. (Medtronic)

Data da decisão2023-06-30

Código do produtoNEZ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging Ltd. (Medtronic). It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230991. 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 SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Given Imaging Ltd. (Medtronic). The 510(k) number is K230991.

When did PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E receive FDA 510(k) clearance?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230991.

Who is the listed applicant for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

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

What is the FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is NEZ.

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Outros registros que listam Given Imaging Ltd. (Medtronic) como candidato(a)

K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Dispositivos Relacionados (Código: NEZ)

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

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