Cleared Traditional

K063795 - GUARDIANCATHETER-URINARY DRAINAGE CATHETER

K063795 is an FDA 510(k) clearance for GUARDIANCATHETER-URINARY DRAINAGE CATHETER, manufactured by Marian Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K063795 · Marian Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
73d
Days
Class 2
Risk

K063795 is an FDA 510(k) clearance for the GUARDIANCATHETER-URINARY DRAINAGE CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Marian Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on March 5, 2007 after a review of 73 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.

View all Marian Medical, Inc. devices

FDA 510(k) Submission Details - K063795

510(k) Number K063795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date March 05, 2007
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 46
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K063795.
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · Coloplast A/S · Oct 2012
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874 · Astra Tech, Inc. · May 2005
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · Astra Tech, Inc. · Dec 2004
SPEEDICATH
K023254 · Coloplast Corp. · Jan 2003