Cleared Traditional

K111450 - MIROCAM CAPSULE ENDOSCOPE SYSTEM

K111450 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 359-day FDA review.

K111450 · Intromedic Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
359d
Days
Class 2
Risk

K111450 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. (North Attleboro, US). The FDA issued a Cleared decision on May 18, 2012 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K111450

510(k) Number K111450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2011
Decision Date May 18, 2012
Days to Decision 359 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
228d slower than avg
Panel avg: 131d · This submission: 359d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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 K111450.
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
K123864 · Given Imaging , Ltd. · Aug 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K123428 · Intromedic Co., Ltd. · May 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421 · Olympus Medical Systems Corp. · Apr 2013
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
K103025 · Given Imaging , Ltd. · May 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
K101250 · Given Imaging , Ltd. · Mar 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · Given Imaging , Ltd. · Jan 2011