The following data is part of a premarket notification filed by Teleflex Medical with the FDA for 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 .
| Device ID | K173321 |
| 510k 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 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd. Morrisville, NC 27560 |
| Contact | Kristen Bisanz |
| Correspondent | Kristen Bisanz Teleflex Medical 3015 Carrington Mill Blvd. Morrisville, NC 27560 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-20 |
| Decision Date | 2018-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801902114126 | K173321 | 000 |
| 20801902199601 | K173321 | 000 |
| 10801902199635 | K173321 | 000 |
| 20801902199571 | K173321 | 000 |
| 20801902216650 | K173321 | 000 |
| 20801902216636 | K173321 | 000 |
| 20801902216629 | K173321 | 000 |
| 20801902216582 | K173321 | 000 |
| 20801902216575 | K173321 | 000 |
| 20801902216551 | K173321 | 000 |
| 20801902199649 | K173321 | 000 |
| 20801902199588 | K173321 | 000 |
| 20801902199595 | K173321 | 000 |
| 10801902114096 | K173321 | 000 |
| 20801902061175 | K173321 | 000 |
| 20801902061151 | K173321 | 000 |
| 30801902114106 | K173321 | 000 |
| 10801902114119 | K173321 | 000 |
| 30801902077869 | K173321 | 000 |
| 20801902061168 | K173321 | 000 |
| 20801902199625 | K173321 | 000 |
| 20801902199618 | K173321 | 000 |
| 20801902216537 | K173321 | 000 |