Liquick X-treme, Liquick X-treme Plus— 510(k) K261418

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K261418 for Liquick X-treme, Liquick X-treme Plus, Substantially Equivalent on 2026-09-23. Applicant: Teleflex Medical. Device class: 2.

Summary

Teleflex Medical cleared two catheters here, Liquick X-treme and Liquick X-treme Plus, under EZD, straight catheters. The record doesn't say what they're used for or how the Plus version differs.

Class II, 21 CFR 876.5130. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).

Teleflex filed from Athlone, Ireland. Review took 146 days (April 30 to September 23, 2026).

Clearance details

Applicant
Teleflex Medical
Product code
Product code EZD
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Athlone, IE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EZD

product code EZD
Injury
864
Malfunction
2,210
Total
3,074

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.