Cleared Traditional

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K093718 · Zutron Medical, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
82d
Days
Class 1
Risk

K093718 is an FDA 510(k) clearance for the ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003. Classified as Bulb, Inflation, For Endoscope (product code FCY), Class I - General Controls.

Submitted by Zutron Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Zutron Medical, LLC devices

Submission Details

510(k) Number K093718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date February 22, 2010
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCY Bulb, Inflation, For Endoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
Definition An Endoscope Bulb Pressurizes The Interior Of An Endoscope. The User Identifies The Presence Of Leaks In The Endoscope By Immersing In Water And Visually Observing For Bubbles.
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.