510(k) K143164
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