Cleared Traditional

K935774 - CURITY FAST-CATH FEMALE CATHETER KIT (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K935774 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
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Apr 1994
Decision
129d
Days
Class 1
Risk

K935774 is an FDA 510(k) clearance for the CURITY FAST-CATH FEMALE CATHETER KIT. Classified as Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile (product code EYT), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 129 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K935774 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 03, 1993
Decision Date April 11, 1994
Days to Decision 129 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 130d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYT Sheath, Corrugated Rubber, 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.