510(k) K212077

Teleflex Rusch SoftSimplastic Foley Catheters by Teleflexmedical, Inc. — Product Code EZL

K212077 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Teleflex Rusch SoftSimplastic Foley Catheters". The FDA issued a decision of Substantially Equivalent on July 27, 2023. 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.