K162522 is an FDA 510(k) clearance for the UltraCath Continuous Nerve block Catheter. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on March 17, 2017, 189 days after receiving the submission on September 9, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K162522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2016 |
| Decision Date | March 17, 2017 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| 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 |