Cleared Traditional

ASI HEMOSTASIS CATHETER (K901336) - FDA 510(k) Clearance

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

K901336 · Advanced Surgical Intervention, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
90d
Days
Class 2
Risk

K901336 is an FDA 510(k) clearance for the ASI HEMOSTASIS CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Advanced Surgical Intervention, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 90 days - within the typical 510(k) review window.

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 Advanced Surgical Intervention, Inc. devices

Submission Details

510(k) Number K901336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date June 20, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 K901336.
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