Cleared Traditional

K103043 - COLORADO CATHETER STERILESURE - NEW NAM...

K103043 is an FDA 510(k) clearance for COLORADO CATHETER STERILESURE - NEW NAM..., manufactured by Adapta Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K103043 · Adapta Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
85d
Days
Class 2
Risk

K103043 is an FDA 510(k) clearance for the COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Adapta Medical, Inc. (Denver, US). The FDA issued a Cleared decision on January 7, 2011 after a review of 85 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 Adapta Medical, Inc. devices

FDA 510(k) Submission Details - K103043

510(k) Number K103043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date January 07, 2011
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZD Catheter, Straight

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