← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NEY — System, Ablation, Microwave And Accessories

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K252632Nanjing Dewen Medical Technology Co., Ltd. · 510k2026-03-02
K253771Nanjing Devin Medical Technology Co., Ltd. · 510k2026-03-02
K250718Emblation Limited · 510k2025-08-08
K241827Canyon Medical, Inc. · 510k2024-09-26
K241825Canyon Medical, Inc. · 510k2024-09-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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