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FDA 510(k)

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

K-Number: K123864 · 2013-08-12

ApplicantGiven Imaging , Ltd.
Decision Date2013-08-12
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2013-08-12 under 510(k) number K123864. 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 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM?

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-12. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K123864.

When did GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM receive FDA 510(k) clearance?

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM received FDA 510(k) clearance on 2013-08-12, under 510(k) number K123864.

Who is the listed applicant for GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM?

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

What is the FDA product code for GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM?

The FDA product code for GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM is NEZ.

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Other records listing Given Imaging , Ltd. as applicant

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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 CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

Official Source

View on FDA Database →

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

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