510(k) · Cleared
ClearedNICO Myriad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nico Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 21, 2016 as substantially equivalent to K955168 (Promex, Inc., 1996) and 2 other predicates after a 225-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 225 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K955168 (1996). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955168 Surgical CutterPromex, Inc. · 1996 · Recalled
- This deviceK161307 NICO MyriadNico Corporation · 2016
- Descendant · cites it directly · 1 of its ownK182340 NICO MyriadNico Corporation · 2018
- Descendant · cites it directly · 1 of its ownK180372 Aurora EvacuatorRebound Therapeutics · 2018
- Descendant · 2 generations on · 0 of its ownK191599 NICO Myriad NOVUSNico Corporation · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK190075 Aurora EvacuatorRebound Therapeutics · 2019
Most influential descendants
Showing 4 of 4 · See all- K182340NICO MyriadNico Corporation · 2018 · cites it directly1descendant
- K180372Aurora EvacuatorRebound Therapeutics · 2018 · cites it directly1descendant
- K191599NICO Myriad NOVUSNico Corporation · 2019 · 2 generations on0descendants
- K190075Aurora EvacuatorRebound Therapeutics · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955168 | Surgical Cutter | Promex, Inc. | 1996 | 2 |
| 0 (this device) | K161307 | NICO Myriad | Nico Corporation | 2016 | — |
| +1 | K182340 | NICO Myriad | Nico Corporation | 2018 | — |
| +1 | K180372 | Aurora Evacuator | Rebound Therapeutics | 2018 | — |
| +2 | K191599 | NICO Myriad NOVUS | Nico Corporation | 2019 | 5 |
| +2 | K190075 | Aurora Evacuator | Rebound Therapeutics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955168 | Surgical CutterSummary page 4…21 CFR § 874.4250 (Class II) Product Code: GEI Secondary Product ERL, HBC Codes: K955168, Promex Surgical Cutter, §878.4400, GEI Predicate Devices: K972865, Promex ENT Tissue Removal System, §874.4250, ERL… | 1996 |
| * | K972865 | Promex Ent Tissue Removal SystemSummary page 4…Secondary Product ERL, HBC Codes: K955168, Promex Surgical Cutter, §878.4400, GEI Predicate Devices: K972865, Promex ENT Tissue Removal System, §874.4250, ERL K002523, Advantage Drive System, §882.4360, HBC, §878.… | 1997 |
| * | K002523 | Advantage Drive SystemSummary page 4…K955168, Promex Surgical Cutter, §878.4400, GEI Predicate Devices: K972865, Promex ENT Tissue Removal System, §874.4250, ERL K002523, Advantage Drive System, §882.4360, HBC, §878.4820, GEY Device Description The Myriad is a minimally invasive surgical system des… | 2000 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K182340 (Nico Corporation, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161307: NICO Myriad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161307
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026