Cleared Traditional

CENTRAL CATHETER TRAY (K781333) - FDA 510(k) Clearance

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

K781333 · Argon Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
83d
Days
Class 2
Risk

K781333 is an FDA 510(k) clearance for the CENTRAL CATHETER TRAY. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Argon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 83 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.

View all Argon Medical Corp. devices

Submission Details

510(k) Number K781333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1978
Decision Date October 24, 1978
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
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 - KGC Tube, Gastro-enterostomy

All 25
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K781333.
PUMA-G Pediatric System
K242211 · Coaptech, Inc. · Apr 2025
PUMA-G System
K223916 · Coaptech, Inc. · Mar 2023
AMT Suture Delivery System
K193612 · Applied Medical Technology, Inc. · Mar 2020
Fidmi Low Profile Enteral Feeding Device
K191844 · Fidmi Medical, Ltd. · Sep 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · Cook Incorporated · Jun 2019
PUMA-G System
K183057 · Coaptech, LLC · Apr 2019