510(k) K261418

Liquick X-treme, Liquick X-treme Plus by Teleflex Medical — Product Code EZD

K261418 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Liquick X-treme, Liquick X-treme Plus". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Teleflex Medical has 42 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 23, 2026
Date Received
Apr 30, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K261418. Report a data issue: hello@regdatalab.com.