# K161307: NICO Myriad

- Pathway: 510(k) (Traditional)
- Applicant: Nico Corporation
- Decided: Dec 21, 2016 after 225 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955168 (1996). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955168: Surgical Cutter, Promex, Inc. (1996) Summary page 4.
- K972865: Promex Ent Tissue Removal System, Promex, Inc. (1997) Summary page 4.
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 4.

## Most influential descendants
- K182340: NICO Myriad (2018), 1 descendant of its own
- K180372: Aurora Evacuator (2018), 1 descendant of its own
- K191599: NICO Myriad NOVUS (2019), 0 descendants of its own
- K190075: Aurora Evacuator (2019), 0 descendants of its own

## Indications for use
The NICO Myriad™ 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. 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) • Intraventricular Tumors/Cysts

Source page: https://510kreport.com/device/K161307
Methodology: https://510kreport.com/methodology