Cleared Traditional

K972102 - RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT

K972102 is an FDA 510(k) clearance for RADIUS PUSH OVER THE GUIDE WIRE PERCUTA..., 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 233-day FDA review.

K972102 · Radius Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
233d
Days
Class 2
Risk

K972102 is an FDA 510(k) clearance for the RADIUS PUSH OVER THE GUIDE WIRE 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 233 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 - K972102

510(k) Number K972102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date January 23, 1998
Days to Decision 233 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
102d slower than avg
Panel avg: 131d · This submission: 233d
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 K972102.
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 PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972025 · 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
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
K973893 · Applied Medical Technologies · Dec 1997