EYC — Catheter, Upper Urinary Tract Class II

FDA Device Classification

Classification Details

Product Code
EYC
Device Class
Class II
Regulation Number
876.5130
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200757deroyal industriesFoley Catheter with Temperature SensorOctober 15, 2020
K061918ge healthcareFOLEY CATHETERS WITH TEMPERATURE PROBEAugust 18, 2006
K041416deroyalEXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERJuly 2, 2004
K925790deroyal industriesEXAC-TEMP & CLINI-TEMP FOLEY CATHETER'SMay 17, 1993
K890310kosan far east ent.STERILE FOLEY CATHETERNovember 30, 1989