510(k) K840292

URETHRAL CATH. TRAY W/BAG by Corpak Co. — Product Code KNX

K840292 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "URETHRAL CATH. TRAY W/BAG". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Corpak Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
January 24, 1984
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