510(k) K072293

FOSSA URETERAL OPEN STENTS by Fossa Medical, Inc. — Product Code FAD

K072293 is an FDA 510(k) premarket notification submitted by Fossa Medical, Inc. for the device "FOSSA URETERAL OPEN STENTS". The FDA issued a decision of Substantially Equivalent on August 6, 2008. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Fossa Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2008
Date Received
August 16, 2007
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