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FDA 510(k)

CapsoCam Plus (SV-3) Capsule Endoscopy System

K-Number: K242643 · 2024-12-04

ApplicantCapsoVision, Inc.
Decision Date2024-12-04
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CapsoCam Plus (SV-3) Capsule Endoscopy System is a medical device manufactured by CapsoVision, Inc.. It received FDA 510(k) clearance on 2024-12-04 under approval number K242643. 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 Endoscopy System?

CapsoCam Plus (SV-3) Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2024-12-04. It is manufactured by CapsoVision, Inc.. The 510(k) number is K242643.

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

CapsoCam Plus (SV-3) Capsule Endoscopy System received FDA 510(k) clearance on 2024-12-04, under approval number K242643.

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

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

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

The FDA product code for CapsoCam Plus (SV-3) Capsule Endoscopy 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 NCT04605302 Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms COMPLETED 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 NCT05822895 Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy RECRUITING NCT05949268 Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel RECRUITING

Other Devices by CapsoVision, Inc.

K161773CapsoCam Plus (SV-3) Capsule Endoscope System K151635CapsoCam (SV-1) K183192CapsoCam Plus (SV-3) K192662CapsoCam Plus (SV-3) Capsule Endoscopy System K252480CE Deliver (DLV)

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. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp.

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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