Cleared Traditional

K911181 - INTIMAX(TM) IRRIGATION CATHETER

K911181 is the FDA 510(k) clearance for INTIMAX(TM) IRRIGATION CATHETER by Applied Vascular Devices, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K911181 · Applied Vascular Devices, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
31d
Days
Class 2
Risk

K911181 is an FDA 510(k) clearance for the INTIMAX(TM) IRRIGATION CATHETER. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on April 18, 1991 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Applied Vascular Devices, Inc. devices

Submission Details

510(k) Number K911181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date April 18, 1991
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 20
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K911181.
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · United States Endoscopy Group, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOCATH
K911487 · United States Endoscopy Group, Inc. · Aug 1991
T-TUBE WHELAN-MOSS
K772292 · Davol, Inc. · Dec 1977