Cleared Traditional

K860599 - ETHOX LAVAGE TUBE

K860599 is an FDA 510(k) clearance for ETHOX LAVAGE TUBE, manufactured by Ethox Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K860599 · Ethox Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1986
Decision
20d
Days
Class 2
Risk

K860599 is an FDA 510(k) clearance for the ETHOX LAVAGE TUBE. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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.

FDA 510(k) Submission Details - K860599

510(k) Number K860599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 11, 1986
Days to Decision 20 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
111d faster than avg
Panel avg: 131d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDH Device Classification - Class 2, Special Controls

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

All 22
Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K860599.
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990
EASI-LAV ADULT GASTRIC LAVAGE KIT
K896573 · Clairson Industries, LLC · Jan 1990
LEONARD TUBE
K892334 · Surgidyne, Inc. · May 1989
DISPOSABLE IRRIGA/ASPIR. SYSTEM
K821496 · Innovative Surgical Products, Inc. · Jun 1982
TUBING, AXIOM SILICONE PENROSE
K781749 · Axiom Medical, Inc. · Dec 1978
THERAPEUTIC APPARATUS, DIERKER TYPE
K770534 · Well Being Ent. · Apr 1978
K860599 · ETHOX LAVAGE TUBE
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