Cleared Traditional

K261418 - Liquick X-treme, Liquick X-treme Plus

K261418 is an FDA 510(k) clearance for Liquick X-treme, manufactured by Teleflex Medical. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K261418 · Teleflex Medical · Gastroenterology & Urology device
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Sep 2026
Decision
146d
Days
Class 2
Risk

K261418 is an FDA 510(k) clearance for the Liquick X-treme, Liquick X-treme Plus. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Teleflex Medical (Athlone, IE). The FDA issued a Cleared decision on September 23, 2026 after a review of 146 days - within the typical 510(k) review window.

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 Teleflex Medical devices

FDA 510(k) Submission Details - K261418

510(k) Number K261418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2026
Decision Date September 23, 2026
Days to Decision 146 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
15d slower than avg
Panel avg: 131d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 79
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