510(k) K191599 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
NICO Myriad NOVUS
| Applicant | Nico Corporation, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Jun 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | Stryker Corporation NICO Myriad Handpiece
Product Number/Product Name:
NN-8000
15x10 MHP;
NN-8001
15x 13 MHP;
NN-8002
15x 25 MHP - MINOP;
NN-8003
13x10 MHP;
NN-8004
13x13 MHP;
NN-8005
15x25 MHP GAAB;
NN-8006
11X10 MHP Open, Classified |
GEI | None listed |
| Nov 26, 2025 | Stryker Corporation NICO Myriad Illumination Pack
Product No. NN-1000
11g Illumination Sleeve/Fiber;
Product No. NN-1001
13g Illumination Sleeve/Fiber Open, Classified |
GEI | None listed |
| Nov 26, 2025 | Stryker Corporation NICO BrainPath;
Product Number/Product Name
NN-8024
BrainPath Shephard's Hook - Greenberg;
NN-8025
BrainPath Shephard's Hook - Sugita;
NN-8026
BrainPath Shephard's Hook - Budde;
NN-8042
BrainPath She Open, Classified |
GEI | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.