510(k) Report

FDA applicant

Shenzhen Trious Medical Technology Co., Ltd.

Shenzhen, CN3 decisions2025–20250 recalls

FDA records 3 decisions for Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN) in 2025: 3 510(k) clearances. Most are in product codes FAD (Stent, Ureteral) and LJE (Catheter, Nephrostomy). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Shenzhen Trious Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2025: 3
2025high 3 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Shenzhen Trious Medical Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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