Cleared Traditional

K973070 - CONVEEN EASICATH SET

K973070 is the FDA 510(k) clearance for CONVEEN EASICATH SET by Coloplast Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K973070 · Coloplast Corp. · Gastroenterology & Urology device
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Nov 1997
Decision
80d
Days
Class 2
Risk

K973070 is an FDA 510(k) clearance for the CONVEEN EASICATH SET. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 80 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 Coloplast Corp. devices

Submission Details

510(k) Number K973070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date November 06, 1997
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.