510(k) K061548

STRYKER URETERAL ILLUMINATION SYSTEM IV by Stryker Corp. — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2006
Date Received
June 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
Review Panel
GU
Submission Type