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FDA 510(k) Application Details - K010568
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K010568
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085-2936 US
Other 510(k) Applications for this Company
Contact
BETTY M JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2001
Decision Date
03/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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