← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FGE — Stents, Drains And Dilators For The Biliary Ducts

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5010
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
15
510(K)/PMA CLEARANCES
510k: 15
0
RECALL ENTRIES

Recent clearances

K253393Hangzhou AGS MedTech Co., Ltd. · 510k2026-06-24
K253832Mirco-Tech (Nanjing) Co., Ltd. · 510k2026-04-24
K251658Medi-Globe GmbH · 510k2026-04-16
K253987GIE Medical · 510k2026-03-13
K253132Zhejiang Chuangxiang Medical Technology Co., Ltd. · 510k2026-03-06
K251123Taewoong Medical Co., Ltd. · 510k2025-12-29
K251019Bioteque Corporation · 510k2025-12-22
K250409Olympus Medical Systems Corporation · 510k2025-10-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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