Cleared Traditional

K926369 - WALTHER CATHETERS

K926369 is an FDA 510(k) clearance for WALTHER CATHETERS, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K926369 · Thomasville Medical Assoc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
150d
Days
Class 2
Risk

K926369 is an FDA 510(k) clearance for the WALTHER CATHETERS, MALE, FEMALE. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on May 21, 1993 after a review of 150 days - an extended review 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: 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 Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K926369

510(k) Number K926369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date May 21, 1993
Days to Decision 150 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
20d slower than avg
Panel avg: 130d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 45
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K926369.
RUSCH FLONEIL
K020714 · Rusch Intl. · Jul 2002
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc. · Aug 2001
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · American Medical Systems, Inc. · Mar 1992
AUTOCATH(TM) SET
K910876 · Cook Urological, Inc. · May 1991
KENDALL CURITY URETHRAL CATHETERS
K892442 · The Kendal Co. · Jun 1989