510(k) K874309

URETHAL CATHETER by Medovations, Inc. — Product Code KNX

K874309 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "URETHAL CATHETER". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type