Cleared Traditional

K964899 - KENDALL CURITY URETERAL CATHETER

K964899 is an FDA 510(k) clearance for KENDALL CURITY URETERAL CATHETER, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K964899 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
66d
Days
Class 2
Risk

K964899 is an FDA 510(k) clearance for the KENDALL CURITY URETERAL CATHETER. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 66 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 - K964899

510(k) Number K964899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date February 07, 1997
Days to Decision 66 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
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EYB Device Classification - Class 2, Special Controls

Product Code EYB Catheter, Ureteral, Gastro-urology
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 - EYB Catheter, Ureteral, Gastro-urology

All 21
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K964899.
AMSURE RED RUBBER URETHRAL CATHETER
K030293 · Amsino International, Inc. · Feb 2004
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc. · Nov 2003
APPLIED URETERAL CATHETER
K020577 · Applied Medical Resources Corp. · May 2002
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · Cook Urological, Inc. · Jun 1996
BARD FLEXIBLE TIP URETERAL CATHETER
K950300 · C.R. Bard, Inc. · Apr 1995
ACU-SIZER(TM)
K941011 · Applied Medical Resources · Jun 1994