Company ยท US
Nico Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2024. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2024 | K232567 | Myriad SPECTRA Light Source Nico Corporation | QFX |
| Sep 13, 2019 | K191599 | NICO Myriad NOVUS Nico Corporation | GEI |
| Sep 20, 2018 | K182340 | NICO Myriad Nico Corporation | GEI |
| Sep 7, 2017 | K172433 | NICO BrainPath Nico Corporation | GZT |
| Dec 21, 2016 | K161307 | NICO Myriad Nico Corporation | GEI |
| Aug 11, 2016 | K162075 | NICO TRIOwand Nico Corporation | GEI |
| Jun 12, 2015 | K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook Nico Corporation | GZT |
| Apr 23, 2015 | K150993 | NICO TRIOwand Nico Corporation | GEI |
| Jun 5, 2012 | K120691 | BRAIN PORT Nico Corporation | GZT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2021 | Nico Corp. Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection
Part Number NN-7013
The Myriad-LX light source is a high-intensity 300W Xenon il Terminated |
GEI | K191599 |
| Apr 30, 2021 | Nico Corp. NICO Myriad-LX Illumination Pack:
REF: NN-1000 Mvriad-LX Illumination Pack. 11ga
REF: NN-1001 Mvriad-LX Illumination Pack. l3ga
Intended to perform resection and removal of soft tissues and fluids un Terminated |
GEI | K191599 |
| Jun 19, 2018 | Nico Corp. NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device
Part Number: NN-8024 Terminated |
GZT | None listed |
| Sep 15, 2015 | Nico Corp. NICO Myriad Console
Model number NN-7000
The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and Terminated |
GEY | K955168 |
| Feb 24, 2014 | Nico Corp. Myriad handpiece
Tissue morcellator Terminated |
GEY | K955168 |
| Aug 13, 2012 | Nico Corp. 13.5 mm x 60 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | K120691 |
| Aug 13, 2012 | Nico Corp. 13.5 mm x 50 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | K120691 |