Cleared Traditional

WORKING CHANNEL VALVE (K900781) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K900781 · Applied Urology, Inc. · Gastroenterology & Urology device
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Apr 1990
Decision
64d
Days
Class 1
Risk

K900781 is an FDA 510(k) clearance for the WORKING CHANNEL VALVE. Classified as Adaptor, Bulbs, Miscellaneous, For Endoscope (product code FFY), Class I - General Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 64 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 Applied Urology, Inc. devices

Submission Details

510(k) Number K900781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date April 25, 1990
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFY Adaptor, Bulbs, Miscellaneous, For Endoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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.