← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
FED — Endoscopic Access Overtube, Gastroenterology-Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES
Recent clearances
K260965Calyxo, Inc. · 510k2026-04-13
K260521Zhuhai Pusen Medical Technology Co., Ltd. · 510k2026-04-06
K252572Prodeon Medical, Inc. · 510k2025-10-07
K250128Anhui Happiness Workshop Medical Instruments Co., Ltd. · 510k2025-09-19
K250132Zhejiang YiGao Medical Technology Co., Ltd. · 510k2025-09-05
K250695Shenzhen HugeMed Medical Technical Development Co., Ltd. · 510k2025-07-08
K251599Hunan Vathin Medical Instrument Co., Ltd. · 510k2025-07-03
K250585Cathegenix (Xiamen) Co., Ltd. · 510k2025-06-27
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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