Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120567
Device Classification Name
Electrode, Electrosurgical, Active, Urological
More FDA Info for this Device
510(K) Number
K120567
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
GYRUS ACMI, INC.
136 TURNPIKE RD.
SOUTHBOROUGH, MA 01772 US
Other 510(k) Applications for this Company
Contact
NEIL KELLY
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2012
Decision Date
06/20/2012
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