DEVICE CLASS
Class II
REGULATION
21 CFR 884.1690
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K253020American Medical Endoscopy, Inc. · 510k2026-06-04
K254050Suzhou AcuVu Medical Technology Co., Ltd. · 510k2026-05-15
K254251Shanghai AnQing Medical Instrument Co., Ltd. · 510k2026-02-26
K252793Jiangsu Jiyuan Medical Technology Co., Ltd. · 510k2025-12-18
K252012Stryker Endoscopy · 510k2025-07-18
K243382Rz Medizintechnik GmbH · 510k2025-06-03
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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