Cleared Traditional

K964219 - ZIP CONDOM CATHETER

K964219 is an FDA 510(k) clearance for ZIP CONDOM CATHETER, manufactured by Goulter Medical, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYZ cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K964219 · Goulter Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
293d
Days
Class 1
Risk

K964219 is an FDA 510(k) clearance for the ZIP CONDOM CATHETER. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Goulter Medical, Inc. (Concord, US). The FDA issued a Cleared decision on August 11, 1997 after a review of 293 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 Goulter Medical, Inc. devices

FDA 510(k) Submission Details - K964219

510(k) Number K964219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date August 11, 1997
Days to Decision 293 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
163d slower than avg
Panel avg: 130d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

EYZ Device Classification - Class 1, General Controls

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.