Cleared Traditional

K150345 - Magic3 Go Intermittent Urinary Catheter

K150345 is an FDA 510(k) clearance for Magic3 Go Intermittent Urinary Catheter, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K150345 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
89d
Days
Class 2
Risk

K150345 is an FDA 510(k) clearance for the Magic3 Go Intermittent Urinary Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 11, 2015 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K150345

510(k) Number K150345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2015
Decision Date May 11, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
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 85
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K150345.
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
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FULL CARE Disposable PVC Nelaton Catheter
K151745 · Shaoxing Fuqing Health Products Co., Ltd. · Mar 2016
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
Well Lead PVC Urethral Catheter
K142563 · Well Lead Medical Co., Ltd. · Oct 2014
COMPACTCATH INTERMITTENT URINARY CATHETER
K140945 · Compactcath, Inc. · Aug 2014
K150345 · Magic3 Go Intermittent Urinary Catheter
Download PDF FDA Summary C.R. Bard, Inc.