DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES
Recent clearances
P230002Microcube, LLC · pma2026-07-13
P180032Channel Medsystems, Inc. · pma2026-07-08
P140013Axora Medical, Inc. · pma2026-02-12
P010013Hologic, Inc. · pma2025-12-17
P160047CooperSurgical, Inc. · pma2025-01-07
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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