Cleared Traditional

K780062 - CATHETER/HEMOSTATIC/GERIATRIC

K780062 is the FDA 510(k) clearance for CATHETER/HEMOSTATIC/GERIATRIC by Kendall Research Center. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K780062 · Kendall Research Center · Gastroenterology & Urology device
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Feb 1978
Decision
33d
Days
Class 2
Risk

K780062 is an FDA 510(k) clearance for the CATHETER/HEMOSTATIC/GERIATRIC. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Kendall Research Center (Mchenry, US). The FDA issued a Cleared decision on February 14, 1978 after a review of 33 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.

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Submission Details

510(k) Number K780062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1978
Decision Date February 14, 1978
Days to Decision 33 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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.