Cleared Traditional

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

K173321 · Teleflex Medical · Anesthesiology

Apr 2018

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number	K173321 FDA.gov
FDA Decision	Cleared 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