Cleared Traditional

K062444 - HI-SLIP AND HI-SLIP PLUS SINGLE USE HYD...

K062444 is an FDA 510(k) clearance for HI-SLIP AND HI-SLIP PLUS SINGLE USE HYD..., manufactured by Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K062444 · Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
185d
Days
Class 2
Risk

K062444 is an FDA 510(k) clearance for the HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. (Durham, US). The FDA issued a Cleared decision on February 22, 2007 after a review of 185 days - an extended review cycle.

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 Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. devices

FDA 510(k) Submission Details - K062444

510(k) Number K062444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date February 22, 2007
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 130d · This submission: 185d
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 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K062444.
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