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FDA 510(k)

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0

K-Number: K170210 · 2017-09-01

ApplicantGiven Imaging , Ltd.
Decision Date2017-09-01
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 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 2017-09-01 under 510(k) number K170210. 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 SBC capsule endoscopy system, PilCam Desktop Software 9.0?

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K170210.

When did PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 receive FDA 510(k) clearance?

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 received FDA 510(k) clearance on 2017-09-01, under 510(k) number K170210.

Who is the listed applicant for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

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 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

The FDA product code for PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 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. 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.

K180171PillCam Patency SystemK170839RAPID WebK151086ManoScan SystemK153466PillCam COLON 2 Capsule Endoscopy System

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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