Cleared Traditional

ASTA-CATH (K961361) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961361 · A+ Products · Gastroenterology & Urology device
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Oct 1996
Decision
205d
Days
Class 2
Risk

K961361 is an FDA 510(k) clearance for the ASTA-CATH. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by A+ Products (West Newton, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 205 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.

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Submission Details

510(k) Number K961361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date October 31, 1996
Days to Decision 205 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
75d slower than avg
Panel avg: 130d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K961361.
SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
CATHETER, SILICONE FOLEY (BARDEX)
K760093 · C.R. Bard, Inc. · Aug 1976
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K760253 · C.R. Bard, Inc. · Aug 1976
TRAY, FOLEY CATHETER
K760254 · C.R. Bard, Inc. · Aug 1976