K160297 is an FDA 510(k) clearance for the Tuohy NRFit. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on October 28, 2016, 268 days after receiving the submission on February 3, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K160297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2016 |
| Decision Date | October 28, 2016 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSP — Needle, Conduction, Anesthetic (w/wo Introducer) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |