510(k) K071229

SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY by Senorx, Inc. — Product Code JAQ

K071229 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY". The FDA issued a decision of SESU on May 18, 2007. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Senorx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
May 18, 2007
Date Received
May 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type