510(k) K060799

COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA by Cosman Medical, Inc. — Product Code GXI

K060799 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA". The FDA issued a decision of Substantially Equivalent on May 2, 2006. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Cosman Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2006
Date Received
March 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type