510(k) K232469

Rüsch Latex Gold Foley Catheter by Teleflexmedical, Inc. — Product Code EZL

K232469 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Rüsch Latex Gold Foley Catheter". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.