Cleared Traditional

K972025 - RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT

K972025 is an FDA 510(k) clearance for RADIUS PULL PERCUTANEOUS ENDOSCOPIC GAS..., manufactured by Radius Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K972025 · Radius Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
235d
Days
Class 2
Risk

K972025 is an FDA 510(k) clearance for the RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Radius Intl., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 235 days - an extended review 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: 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 Radius Intl., Inc. devices

FDA 510(k) Submission Details - K972025

510(k) Number K972025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date January 23, 1998
Days to Decision 235 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 131d · This submission: 235d
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 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K972025.
VYGON NEO-SUMP
K974806 · Vygon Corp. · Mar 1998
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
K973409 · Davis & Geck, Inc. · Feb 1998
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
K972478 · Applied Medical Technologies · Feb 1998
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972102 · Radius Intl., Inc. · Jan 1998
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
K971901 · Radius Intl., Inc. · Jan 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998