Cleared Traditional

K123428 - MIROCAM CAPSULE ENDOSCOPE SYSTEM

K123428 is an FDA 510(k) clearance for MIROCAM CAPSULE ENDOSCOPE SYSTEM, manufactured by Intromedic Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code NEZ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K123428 · Intromedic Co., Ltd. · Gastroenterology & Urology device
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May 2013
Decision
194d
Days
Class 2
Risk

K123428 is an FDA 510(k) clearance for the MIROCAM CAPSULE ENDOSCOPE SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Intromedic Co., Ltd. (Guro-Gu , Seoul, KR). The FDA issued a Cleared decision on May 20, 2013 after a review of 194 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intromedic Co., Ltd. devices

FDA 510(k) Submission Details - K123428

510(k) Number K123428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2012
Decision Date May 20, 2013
Days to Decision 194 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 131d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEZ Device Classification - Class 2, Special Controls

Product Code NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

All 46
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K123428.
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K134005 · Intromedic Co., Ltd. · Jul 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751 · Intromedic Co., Ltd. · Jun 2014
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
K123864 · Given Imaging , Ltd. · Aug 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421 · Olympus Medical Systems Corp. · Apr 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K111450 · Intromedic Co., Ltd. · May 2012
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
K103025 · Given Imaging , Ltd. · May 2011