Cleared Traditional

Liv Pre-lubricated Intermittent Catheter

K260502 · HR Healthcare · Gastroenterology & Urology
Mar 2026
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K260502 is an FDA 510(k) clearance for the Liv Pre-lubricated Intermittent Catheter, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by HR Healthcare (York, US). The FDA issued a Cleared decision on March 12, 2026, 27 days after receiving the submission on February 13, 2026. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K260502 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2026
Decision Date March 12, 2026
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZD — Catheter, Straight
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

Similar Devices — EZD Catheter, Straight

All 78
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits
K251274 · HR Healthcare · Jan 2026
Ready to use Nelaton Catheter
K251178 · Jamjoom Fullcare Corporation · Jan 2026
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
K251468 · Hollister Incorporated · Oct 2025
LoFric Origo
K250659 · Wellspect AB · Sep 2025
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
K250699 · Convatec · Jul 2025
Luja Coud?
K251116 · Coloplast Corp. · Jun 2025