Cleared Traditional

K822743 - SOLID STATE CONTINUOUS FLOW CONTROL

K822743 is the FDA 510(k) clearance for SOLID STATE CONTINUOUS FLOW CONTROL by Widran Urological Group, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code LJH) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K822743 · Widran Urological Group, Ltd. · Gastroenterology & Urology device
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Sep 1982
Decision
14d
Days
Class 2
Risk

K822743 is an FDA 510(k) clearance for the SOLID STATE CONTINUOUS FLOW CONTROL. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Widran Urological Group, Ltd. (Walker, US). The FDA issued a Cleared decision on September 24, 1982 after a review of 14 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 Widran Urological Group, Ltd. devices

Submission Details

510(k) Number K822743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1982
Decision Date September 24, 1982
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJH System, Irrigation, Urological
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.