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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 the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) 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. The listed applicant is CapsoVision, Inc.. The 510(k) number is K242643.

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

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

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

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

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)K192662CapsoCam Plus (SV-3) Capsule Endoscopy SystemK183192CapsoCam Plus (SV-3)K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemK151635CapsoCam (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.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)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies 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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