K143164 is an FDA 510(k) clearance for the ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Kimberly Clark Corporation (Irvine, US). The FDA issued a Cleared decision on December 2, 2014, 29 days after receiving the submission on November 3, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K143164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2014 |
| Decision Date | December 02, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSO - Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |