Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nico Corporation with 9 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Mar 14, 2024: Myriad SPECTRA Light Source.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 14, 2024 | Myriad SPECTRA Light SourceK232567 · QFX | 510(k) clearances |
| Apr 30, 2021 | Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 Class II · (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery slee | Device recalls |
| Apr 30, 2021 | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga IntendeClass II · (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery slee | Device recalls |
| Sep 13, 2019 | NICO Myriad NOVUSK191599 · GEI | 510(k) clearances |
| Sep 20, 2018 | NICO MyriadK182340 · GEI | 510(k) clearances |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024Class II · Mislabeled hook pouch included a transport/storage label rather than the product label containing key product informati | Device recalls |
| Sep 7, 2017 | NICO BrainPathK172433 · GZT | 510(k) clearances |
| Dec 21, 2016 | NICO MyriadK161307 · GEI | 510(k) clearances |
| Aug 11, 2016 | NICO TRIOwandK162075 · GEI | 510(k) clearances |
| Jul 29, 2015 | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. Class II · Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables ma | Device recalls |
| Jun 12, 2015 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookK150378 · GZT | 510(k) clearances |
| Apr 23, 2015 | NICO TRIOwandK150993 · GEI | 510(k) clearances |
| Feb 24, 2014 | Myriad handpiece Tissue morcellatorClass II · This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail | Device recalls |
| Jul 17, 2012 | 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 Class II · BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label doe | Device recalls |
| Jul 17, 2012 | 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 Class II · BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label doe | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
