# K191599: NICO Myriad NOVUS

- Pathway: 510(k) (Traditional)
- Applicant: Nico Corporation
- Decided: Sep 13, 2019 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955168 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182340: NICO Myriad, Nico Corporation (2018) Summary page 4.

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0599-2026: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Oct 31, 2025 · Class II · Z-0600-2026: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Oct 31, 2025 · Class II · Z-0601-2026: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Apr 30, 2021 · Class II · Z-1839-2021: (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some
- Apr 30, 2021 · Class II · Z-1840-2021: (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some

## Indications for use
The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following: - Primary/Secondary Brain Tumors - Vascular Abnormalities/Malformations (e.g., hemangiomas, cavernomas, and hematoma evacuation/ICH) - Intraventricular Tumors/Cysts The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue. The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.

Source page: https://510kreport.com/device/K191599
Methodology: https://510kreport.com/methodology