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FDA 510(k)

MiroCam® Capsule Endoscope System

K-Number: K252617 · 2026-05-08

ApplicantIntromedic Co., Ltd.
Decision Date2026-05-08
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MiroCam® Capsule Endoscope System is a medical device manufactured by Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2026-05-08 under approval number K252617. 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 2026-05-08. It is manufactured by Intromedic Co., Ltd.. The 510(k) number is K252617.

When was MiroCam® Capsule Endoscope System approved by the FDA?

MiroCam® Capsule Endoscope System received FDA 510(k) clearance on 2026-05-08, under approval number K252617.

What company makes MiroCam® Capsule Endoscope System?

MiroCam® Capsule Endoscope System is manufactured by Intromedic Co., Ltd..

What is the FDA product code for MiroCam® Capsule Endoscope System?

The FDA product code for MiroCam® Capsule Endoscope System is NEZ.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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