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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 the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) 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. The listed applicant is CapsoVision, Inc.. The 510(k) number is K161773.

When did CapsoCam Plus (SV-3) Capsule Endoscope System receive FDA 510(k) clearance?

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

Who is the listed applicant for CapsoCam Plus (SV-3) Capsule Endoscope System?

The FDA 510(k) record lists CapsoVision, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07089615Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy ReferenceRECRUITING

Other records listing CapsoVision, Inc. 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.

K252480CE Deliver (DLV)K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemK192662CapsoCam Plus (SV-3) Capsule Endoscopy SystemK183192CapsoCam Plus (SV-3)K151635CapsoCam (SV-1)

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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