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FDA 510(k)

MIROCAM CAPSULE ENDOSCOPE SYSTEM

K-Number: K123428 · 2013-05-20

ApplicantIntromedic Co., Ltd.
Decision Date2013-05-20
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MIROCAM CAPSULE ENDOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2013-05-20 under 510(k) number K123428. 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 MIROCAM CAPSULE ENDOSCOPE SYSTEM?

MIROCAM CAPSULE ENDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-20. The listed applicant is Intromedic Co., Ltd.. The 510(k) number is K123428.

When did MIROCAM CAPSULE ENDOSCOPE SYSTEM receive FDA 510(k) clearance?

MIROCAM CAPSULE ENDOSCOPE SYSTEM received FDA 510(k) clearance on 2013-05-20, under 510(k) number K123428.

Who is the listed applicant for MIROCAM CAPSULE ENDOSCOPE SYSTEM?

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

What is the FDA product code for MIROCAM CAPSULE ENDOSCOPE SYSTEM?

The FDA product code for MIROCAM CAPSULE ENDOSCOPE SYSTEM is NEZ.

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Other records listing Intromedic Co., Ltd. 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.

K252617MiroCam® Capsule Endoscope SystemK180732MiroCam Capsule Endoscope SystemK170438MiroCam Capsule Endoscope SystemK131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMK120702E.G. SCAN II ESPHAGOSCOPE SYSTEMK111450MIROCAM CAPSULE ENDOSCOPE SYSTEM

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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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