Cleared Traditional

ICATH, STERILESURE (K071496) - FDA 510(k) Clearance

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

K071496 · Colorado Catheter Company, Inc. · Gastroenterology & Urology device
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Aug 2007
Decision
76d
Days
Class 2
Risk

K071496 is an FDA 510(k) clearance for the ICATH, STERILESURE. Classified as Kit, Catheter, Urinary (exludes Hiv Testing) (product code NWO), Class II - Special Controls.

Submitted by Colorado Catheter Company, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Colorado Catheter Company, Inc. devices

Submission Details

510(k) Number K071496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 31, 2007
Decision Date August 15, 2007
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NWO Kit, Catheter, Urinary (exludes Hiv Testing)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
Definition Urinary Catheterization Kit (excludes Hiv Testing)
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.