510(k) K925282

UROLOGICAL CATHETER AND ACCESSORIES by Applied Urology, Inc. — Product Code FAD

K925282 is an FDA 510(k) premarket notification submitted by Applied Urology, Inc. for the device "UROLOGICAL CATHETER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 13, 1993. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Applied Urology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1993
Date Received
October 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type