DEVICE CLASS
Class II
REGULATION
21 CFR 876.5880
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K260456Traferox Technologies, Inc. · 510k2026-06-01
K254305Paragonix Technologies, Inc. · 510k2026-01-30
K243618Bridge TO Life · 510k2025-06-17
K243870Traferox Technologies, Inc. · 510k2025-05-01
K243998Institut Geroges Lopez · 510k2025-04-25
K243384Bridge TO Life · 510k2025-03-31
K243840Bridge TO Life · 510k2025-03-26
K240650Traferox Technologies, Inc. · 510k2024-11-26
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.
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