DEVICE CLASS
Class II
REGULATION
21 CFR 884.6160
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
K241626Ipreg Incorporation · 510k2025-02-20
K241454Guangzhou Hehong Biotech Co., Ltd. · 510k2025-02-03
K241348Motilitycount Aps · 510k2025-01-31
K241341Fujifilm Irvine Scientific · 510k2024-09-26
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.