Cleared Traditional

K262056 - Rusch Latex Gold Foley Catheter

K262056 is an FDA 510(k) clearance for Rusch Latex Gold Foley Catheter, manufactured by Teleflex Medical Sdn. Bhd.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K262056 · Teleflex Medical Sdn. Bhd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
48d
Days
Class 2
Risk

K262056 is an FDA 510(k) clearance for the Rusch Latex Gold Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Teleflex Medical Sdn. Bhd. (Kamunting, MY). The FDA issued a Cleared decision on August 5, 2026 after a review of 48 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 Teleflex Medical Sdn. Bhd. devices

FDA 510(k) Submission Details - K262056

510(k) Number K262056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2026
Decision Date August 05, 2026
Days to Decision 48 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
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 100
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K262056.
Rusch SoftSimplastic Foley Catheters
K252537 · Teleflex Medical Sdn. Bhd. · Jan 2026
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · Guangdong Ecan Medical Co., Ltd. · Jun 2025
InnoCare Specialty Foley Catheter
K241424 · Innocare Urologics, LLC · Sep 2024
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024
Folysil Silicone Catheter
K233411 · Coloplast Corp. · Apr 2024