K173321 is an FDA 510(k) clearance for the StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on April 25, 2018, 187 days after receiving the submission on October 20, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K173321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2017 |
| Decision Date | April 25, 2018 |
| Days to Decision | 187 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 |