DEVICE CLASS
Class II
REGULATION
21 CFR 884.5160
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
58
510(K)/PMA CLEARANCES
510k: 58
0
RECALL ENTRIES
Recent clearances
K261199Shenzhen TPH Technology Co., Ltd. · 510k2026-07-13
K250070Shenzhen Changkun Technology Co., Ltd. · 510k2026-06-26
K261025Shenzhen Qinyi Electronic Technology Co., Ltd. · 510k2026-06-25
K254254Shenzhen Root Innovation Technology Co., Ltd. · 510k2026-06-18
K260538Shenzhen Root Innovation Technology Co., Ltd. · 510k2026-06-17
K260346Polybell (Guangzhou) Limited · 510k2026-06-12
K250129Avita Corporation · 510k2026-06-11
K260864Shenzhen TPH Technology Co., Ltd. · 510k2026-06-09
Related on SPEQ
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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