NEYClass II

System, Ablation, Microwave And Accessories

21 CFR 878.4400 / General, Plastic Surgery

NEY is the FDA product code for System, Ablation, Microwave And Accessories, a class II device type, regulated under 21 CFR 878.4400. As of 2026-09-10, FDA records hold 68 510(k) clearances under this code, the most recent dated 2026-03-02, and 27 recalls.

Classification record

Product code: NEY
Device name: System, Ablation, Microwave And Accessories
Regulation: 21 CFR 878.4400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 68
Ingested recalls: 27

Clearances, product code NEY

By decision year

68 clearances under product code NEY with a decision year between 2001 and 2026, 2023 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code NEY by decision year
Year	Clearances
2001	1
2002	2
2004	1
2006	3
2007	2
2008	3
2009	4
2010	3
2012	3
2013	1
2014	1
2015	2
2016	3
2017	3
2018	3
2019	2
2020	7
2021	4
2022	1
2023	9
2024	7
2025	1
2026	2

Applicants with the most clearances

Product code NEY

Applicants holding the most 510(k) clearances under product code NEY
Applicant	Clearances
Neuwave Medical, Inc.	10
Medtronic, Inc.	7
Boston Scientific Corporation	6
Creo Medical Ltd	4
Emblation Limited	4
Medwaves Incorporated	3
miraDry, Inc.	3
Afx, Inc.	2
Betters(Suzhou) Medical Co., Ltd	2
Bsd Medical Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order