About This 510(k) Submission
K972102 is an FDA 510(k) clearance for the RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Radius Intl., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on January 23, 1998, 233 days after receiving the submission on June 4, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.