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FDA 510(k)

CapsoCam Plus (SV-3) Capsule Endoscope System

K-Number: K161773 · 2016-10-21

ApplicantCapsoVision, Inc.
Decision Date2016-10-21
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CapsoCam Plus (SV-3) Capsule Endoscope System is a medical device manufactured by CapsoVision, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K161773. 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 CapsoCam Plus (SV-3) Capsule Endoscope System?

CapsoCam Plus (SV-3) Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by CapsoVision, Inc.. The 510(k) number is K161773.

When was CapsoCam Plus (SV-3) Capsule Endoscope System approved by the FDA?

CapsoCam Plus (SV-3) Capsule Endoscope System received FDA 510(k) clearance on 2016-10-21, under approval number K161773.

What company makes CapsoCam Plus (SV-3) Capsule Endoscope System?

CapsoCam Plus (SV-3) Capsule Endoscope System is manufactured by CapsoVision, Inc..

What is the FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System?

The FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System is NEZ.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT06748911 Navicam for Detection of Barrett's Esophagus RECRUITING NCT02910479 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius) COMPLETED

Other Devices by CapsoVision, Inc.

K151635CapsoCam (SV-1) K183192CapsoCam Plus (SV-3) K192662CapsoCam Plus (SV-3) Capsule Endoscopy System K242643CapsoCam Plus (SV-3) Capsule Endoscopy System K252480CE Deliver (DLV)

Related Devices (Code: NEZ)

K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. 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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