Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K173321 |
Device Name |
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 |
Applicant |
Teleflex Medical |
3015 Carrington Mill Blvd. |
Morrisville,
NC
27560
|
|
Applicant Contact |
Kristen Bisanz |
Correspondent |
Teleflex Medical |
3015 Carrington Mill Blvd. |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Kristen Bisanz |
Regulation Number | 868.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/20/2017 |
Decision Date | 04/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|