Cleared Traditional

K933399 - KENDALL URODYNAMIC CATHETERS

K933399 is an FDA 510(k) clearance for KENDALL URODYNAMIC CATHETERS, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K933399 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
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Nov 1993
Decision
113d
Days
Class 2
Risk

K933399 is an FDA 510(k) clearance for the KENDALL URODYNAMIC CATHETERS. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K933399

510(k) Number K933399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date November 02, 1993
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

All 16
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K933399.
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391 · Surgitek · Feb 1995
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · Life-Tech Intl., Inc. · Mar 1994
STAND ALONE CYSTOMETROGRAM
K934141 · Medical Engineering Corp. · Nov 1993
SILICONE RECTAL BALLOON
K930135 · Cook Urological, Inc. · Oct 1993
BARD URODYNAMIC CATHETER
K924714 · C.R. Bard, Inc. · Sep 1993