Cleared Traditional

K882647 - GESCO CATHETERIZATION TRAY

K882647 is the FDA 510(k) clearance for GESCO CATHETERIZATION TRAY by Gesco Intl., Inc.. It is a Class 1 General & Plastic Surgery device (product code GBQ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K882647 · Gesco Intl., Inc. · General & Plastic Surgery device
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Sep 1988
Decision
74d
Days
Class 1
Risk

K882647 is an FDA 510(k) clearance for the GESCO CATHETERIZATION TRAY. Classified as Catheter, Continuous Irrigation (product code GBQ), Class I - General Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K882647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received June 27, 1988
Decision Date September 09, 1988
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBQ Catheter, Continuous Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.