510(k) K914692

URINARY DIVERSION EVACUATING CATHETER by Cook Urological, Inc. — Product Code EXD

K914692 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "URINARY DIVERSION EVACUATING CATHETER". The FDA issued a decision of Substantially Equivalent on July 2, 1992. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1992
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
Submission Type