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FDA 510(k)

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

K-Number: K230991 · 2023-06-30

ApplicantGiven Imaging Ltd. (Medtronic)
Decision Date2023-06-30
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07633847A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.NOT_YET_RECRUITING

Other records listing Given Imaging Ltd. (Medtronic) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Related Devices (Code: NEZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CorporationK221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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