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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 a medical device manufactured by Given Imaging , Ltd.. It received FDA 510(k) clearance on 2017-09-01 under approval 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. It is manufactured by Given Imaging , Ltd.. The 510(k) number is K170210.

When was PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 approved by the FDA?

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

What company makes PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0?

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 is manufactured by Given Imaging , Ltd..

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.

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Other Devices by Given Imaging , Ltd.

K151086ManoScan System K153466PillCam COLON 2 Capsule Endoscopy System K170839RAPID Web K180171PillCam Patency System

Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170839RAPID WebGiven Imaging , Ltd. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp. K180732MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.

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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