510(k) K251864

Rubber Utility Catheter by C.R. Bard, Inc. — Product Code KOD

K251864 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Rubber Utility Catheter". The FDA issued a decision of Substantially Equivalent on February 23, 2026. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2026
Date Received
June 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type