510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K062444Substantially Equivalent

Hi-Slip and Hi-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit

Oasis Medikal Urunler Kimya Sanayi ve Tic A.S., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062444 is the FDA 510(k) clearance record for HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT, a class II device, cleared for Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. on under FDA product code EZD (Catheter, Straight). FDA records list one 510(k) clearance for Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. As of , FDA records show no recalls naming K062444.

Clearance record

Decision date
Received
(185 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. 208 Barrington Overlook, Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260