Cleared Traditional

K852552 - COONS GASTROSTICK SYSTEM

K852552 is an FDA 510(k) clearance for COONS GASTROSTICK SYSTEM, manufactured by Medi-Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K852552 · Medi-Tech, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
122d
Days
Class 2
Risk

K852552 is an FDA 510(k) clearance for the COONS GASTROSTICK SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 122 days - within the typical 510(k) review window.

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: 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 Medi-Tech, Inc. devices

FDA 510(k) Submission Details - K852552

510(k) Number K852552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1985
Decision Date October 17, 1985
Days to Decision 122 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
9d faster than avg
Panel avg: 131d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 416
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K852552.
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI
K853253 · Corpak Co. · Nov 1985
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · E-Z-Em, Inc. · Nov 1985
FEEDING UNITS & TUBES
K853288 · I M, Inc. · Oct 1985
MIC JEJUNAL FEEDING TUBE
K853197 · Medical Innovations Corp. · Aug 1985
GASTRO-ENTEROSTOMY TUBE
K852707 · Medical Innovations Corp. · Aug 1985