Cleared Traditional

UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 (K961906) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K961906 · Spectrum Medsystems Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
187d
Days
Class 1
Risk

K961906 is an FDA 510(k) clearance for the UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016.... Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Spectrum Medsystems Corp. (Irvine, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrum Medsystems Corp. devices

Submission Details

510(k) Number K961906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date November 19, 1996
Days to Decision 187 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
57d slower than avg
Panel avg: 130d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, 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.