Company ยท FI
Nexstim OY
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2019. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2019 | K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc, FI | OBP |
| Nov 10, 2017 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc, FI | OBP |
| May 22, 2012 | K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) Nexstim OY, FI | GWF |
| Dec 8, 2009 | K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM Nexstim OY | GWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Nexstim PLC NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1.
The Nexstim Navigated Brain Stimulation System (NBS System) is Open, Classified |
GWF | K112881 |
| May 22, 2017 | Nexstim PLC Nexstim eXima NBS System Software version 2.2 or higher.
The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i Open, Classified |
GWF | K091457 |