DEVICE CLASS
Class II
REGULATION
21 CFR 880.6850
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES
Recent clearances
K261897O&M Halyard, Inc. · 510k2026-07-02
K252823Dukal, LLC · 510k2026-05-28
K253454O&M Halyard, Inc. · 510k2026-05-18
K251347Sterivic Medical Co., Ltd. · 510k2026-01-28
K251177Guangdong Maidi Medical Co., Ltd. · 510k2025-12-12
K250306Propper Manufacturing Co., Inc. · 510k2025-10-31
K243179Yichang Xinxin Paper Products Co., Ltd. · 510k2025-06-26
K250321George Courey, Inc. · 510k2025-06-06
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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