510(k) K143164

ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set by Kimberly-Clark Corporation — Product Code BSO

K143164 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corporation for the device "ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set". The FDA issued a decision of Substantially Equivalent on December 2, 2014. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Kimberly-Clark Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2014
Date Received
November 3, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type