Cleared Traditional

K040494 - CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143

Also marketed or referenced as:
CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

K040494 is an FDA 510(k) clearance for CAPSULE DELIVERY DEVICE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NEZ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K040494 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
118d
Days
Class 2
Risk

K040494 is an FDA 510(k) clearance for the CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on June 23, 2004 after a review of 118 days - within the typical 510(k) review window.

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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K040494

510(k) Number K040494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date June 23, 2004
Days to Decision 118 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 131d · This submission: 118d
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 40
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K040494.
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