The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Echoglo Needle.
| Device ID | K171968 |
| 510k Number | K171968 |
| Device Name: | EchoGlo Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Michael R. Johnson |
| Correspondent | Michael R. Johnson Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2018-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517086953 | K171968 | 000 |
| 35019517065965 | K171968 | 000 |
| 35019517065972 | K171968 | 000 |
| 55019517065983 | K171968 | 000 |
| 55019517065990 | K171968 | 000 |
| 55019517066003 | K171968 | 000 |
| 35019517086885 | K171968 | 000 |
| 55019517086896 | K171968 | 000 |
| 35019517086908 | K171968 | 000 |
| 55019517086919 | K171968 | 000 |
| 35019517086922 | K171968 | 000 |
| 55019517086933 | K171968 | 000 |
| 35019517086946 | K171968 | 000 |
| 55019517065952 | K171968 | 000 |