DEVICE CLASS
Class II
REGULATION
21 CFR 884.5300
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K252158Mayer Laboratories · 510k2026-03-30
K243967Global Protection Corp. · 510k2025-04-08
K241617Rb Health (Us), LLC · 510k2025-02-28
K240379Church & Dwight Co., Inc. · 510k2024-10-08
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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