Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113692
Device Classification Name
Endoscopic Guidewire, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K113692
Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Applicant
XENOLITH MEDICAL
1 LESHEM,
P.O. BOX 720
KITYAT-GAT 82000 IL
Other 510(k) Applications for this Company
Contact
OFER ZIGMAN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2011
Decision Date
08/09/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact