Nico Corp.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1840-2021Class IIMyriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissuApril 30, 2021
Z-1839-2021Class IINICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 MvriApril 30, 2021
Z-2822-2018Class IINICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NNJune 19, 2018
Z-2767-2015Class IINICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically deJuly 29, 2015
Z-2045-2016Class IIMyriad handpiece Tissue morcellatorFebruary 24, 2014
Z-2201-2012Class II13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multJuly 17, 2012
Z-2200-2012Class II13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multJuly 17, 2012