FDA 510(k)

AdvanCE capsule endoscope delivery device

K-Number: K163495 · 2017-03-10

ApplicantUnited States Endoscopy Group, Inc.

Decision Date2017-03-10

Product CodeNEZ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AdvanCE capsule endoscope delivery device is a medical device manufactured by United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-03-10 under approval number K163495. 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 AdvanCE capsule endoscope delivery device?

AdvanCE capsule endoscope delivery device is a medical device that received FDA 510(k) clearance on 2017-03-10. It is manufactured by United States Endoscopy Group, Inc.. The 510(k) number is K163495.

When was AdvanCE capsule endoscope delivery device approved by the FDA?

AdvanCE capsule endoscope delivery device received FDA 510(k) clearance on 2017-03-10, under approval number K163495.

What company makes AdvanCE capsule endoscope delivery device?

AdvanCE capsule endoscope delivery device is manufactured by United States Endoscopy Group, Inc..

What is the FDA product code for AdvanCE capsule endoscope delivery device?

The FDA product code for AdvanCE capsule endoscope delivery device is NEZ.

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Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. K170839RAPID WebGiven Imaging , Ltd. 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.