DEVICE CLASS
Class II
REGULATION
21 CFR 876.1075
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES
Recent clearances
K261196Promisemed Hangzhou Meditech Co., Ltd. · 510k2026-05-12
K260365Devicor Medical Products, Inc. · 510k2026-03-04
K252795Argon Medical Devices, Inc. · 510k2026-02-23
K252681Bard Peripheral Vascular, Inc. · 510k2025-12-12
K252183Resitu Medical AB · 510k2025-09-24
K243407Forcyte Medical, LLC · 510k2025-07-29
K244018Zhejiang Curaway Medical Technology Co., Ltd. · 510k2025-07-22
K243296Carbon (Shenzhen) Medical Device Co., Ltd. · 510k2025-07-11
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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