Cleared Traditional

K831244 - URETERAL STONE EXTRACTOR CATHETER

K831244 is an FDA 510(k) clearance for URETERAL STONE EXTRACTOR CATHETER, manufactured by American Edwards Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K831244 · American Edwards Laboratories · Gastroenterology & Urology device
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Jun 1983
Decision
60d
Days
Class 2
Risk

K831244 is an FDA 510(k) clearance for the URETERAL STONE EXTRACTOR CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983 after a review of 60 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 American Edwards Laboratories devices

FDA 510(k) Submission Details - K831244

510(k) Number K831244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date June 17, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 131d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K831244.
CURITY CATHETER STRAP
K832692 · The Kendal Co. · Sep 1983
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K831567 · Mallinckrodt Critical Care · Aug 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983
STERILE, ALL PURPOSE URETHRAL CATHETER
K830444 · Abco Dealers, Inc. · Mar 1983
CATHETER HOLDER
K823818 · Danek Medical, Inc. · Jan 1983
RETRIEVAL BALLOONS
K821818 · American Endoscopy, Inc. · Sep 1982