Cleared Traditional

K134005 - MIROCAM CAPSULE ENDOSCOPE SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K134005 · Intromedic Co., Ltd. · Gastroenterology & Urology device
Jul 2014
Decision
194d
Days
Class 2
Risk

K134005 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 July 9, 2014 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.

Submission Details

510(k) Number K134005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2013
Decision Date July 09, 2014
Days to Decision 194 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 156d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.