DEVICE CLASS
Class II
REGULATION
21 CFR 884.2740
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES
Recent clearances
K253021Sibel Health, Inc. · 510k2026-02-26
K250777Huntleigh Healthcare , Ltd. · 510k2025-09-19
K241882Edan Instruments, Inc. · 510k2025-08-27
K241368Huntleigh Healthcare , Ltd. · 510k2025-02-03
K241009Perigen, Inc. · 510k2025-01-10
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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