Cleared Traditional

K944135 - UROLOGICAL GUIDWIRE

K944135 is an FDA 510(k) clearance for UROLOGICAL GUIDWIRE, manufactured by Applied Medical Resources. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K944135 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
28d
Days
Class 2
Risk

K944135 is an FDA 510(k) clearance for the UROLOGICAL GUIDWIRE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on September 21, 1994 after a review of 28 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K944135

510(k) Number K944135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1994
Decision Date September 21, 1994
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K944135.
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · The Kendal Co. · Apr 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · Orion Life Systems, Inc. · Jan 1995
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · Boston Scientific Corp · Oct 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · Boston Scientific Corp · Jul 1994
SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE
K935643 · Regulatory & Marketing Services, Inc. · Jun 1994
FLEXI-TRAK ANCHORING DEVICE
K932143 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993