Cleared Traditional

K926344 - HYDROPHILIC COATED GUIDEWIRE

K926344 is an FDA 510(k) clearance for HYDROPHILIC COATED GUIDEWIRE, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K926344 · Surgitek · Gastroenterology & Urology device
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Mar 1993
Decision
78d
Days
Class 2
Risk

K926344 is an FDA 510(k) clearance for the HYDROPHILIC COATED GUIDEWIRE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 78 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 Surgitek devices

FDA 510(k) Submission Details - K926344

510(k) Number K926344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1992
Decision Date March 05, 1993
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
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 30
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K926344.
FLEXI-TRAK ANCHORING DEVICE
K932143 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K925161 · North American Sterilization & Packaging Co. · Jul 1993
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
GUIDEWIRE
K921200 · Lake Region Mfg., Inc. · Sep 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991