Cleared Traditional

K772402 - QUADRIPLEGIC URINARY DRAINAGE VALVE

K772402 is an FDA 510(k) clearance for QUADRIPLEGIC URINARY DRAINAGE VALVE, manufactured by Fred Sammons, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FAQ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K772402 · Fred Sammons, Inc. · Gastroenterology & Urology device
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Jan 1978
Decision
30d
Days
Class 1
Risk

K772402 is an FDA 510(k) clearance for the QUADRIPLEGIC URINARY DRAINAGE VALVE. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K772402

510(k) Number K772402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date January 26, 1978
Days to Decision 30 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

FAQ Device Classification - Class 1, General Controls

Product Code FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.