Cleared Traditional

K973546 - KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

K973546 is an FDA 510(k) clearance for KENDALL FAST-CATH PRE LUBRICATED URETHR..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
50d
Days
Class 2
Risk

K973546 is an FDA 510(k) clearance for the KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 7, 1997 after a review of 50 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K973546

510(k) Number K973546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1997
Decision Date November 07, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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.

Regulatory Peers - EZD Catheter, Straight

All 84
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K973546.
VITALCARE URETHRAL CATHETER RED RUBBER
K023872 · Vitalcare, Inc. · Apr 2003
AMERICAN CATHETER, MODEL W3
K030538 · Catheter, LLC · Mar 2003
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
K993226 · Memcath Technologies, LLC · Dec 1999
CONVEEN EASICATH SET
K973070 · Coloplast Corp. · Nov 1997
ORION RED URETHRAL CATHETER
K944383 · Regulatory & Marketing Services, Inc. · Dec 1994
GOOSEN SELF-LUBRICATING CATHETER
K923848 · Goosen Enterprises, Inc. · Feb 1994