Cleared Traditional

K973120 - READYCATH CATHETER

K973120 is an FDA 510(k) clearance for READYCATH CATHETER, manufactured by Medical Technologies of Georgia. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K973120 · Medical Technologies of Georgia · Gastroenterology & Urology device
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Feb 1998
Decision
189d
Days
Class 2
Risk

K973120 is an FDA 510(k) clearance for the READYCATH CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Medical Technologies of Georgia (Decatur, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 189 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 Medical Technologies of Georgia devices

FDA 510(k) Submission Details - K973120

510(k) Number K973120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date February 25, 1998
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 131d · This submission: 189d
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 54
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K973120.
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc. · Aug 2001
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · Sc Hennig Enterprises Europe Srl · Dec 1999
UROLOGICAL CATHETER
K992137 · Apogee, Inc. · Sep 1999
PERSONAL CATHETER
K970704 · Rochester Medical Corp. · Mar 1997
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
ASTA-CATH
K961361 · A+ Products · Oct 1996