510(k) Report

FDA applicant

Dongguan Zsr Biomedical Technology Company Limited

Dongguan, CN2 decisions2024–20250 recalls

FDA records 2 decisions for Dongguan Zsr Biomedical Technology Company Limited (Dongguan, CN) from 2024 to 2025: 2 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and FED (Endoscopic Access Overtube…). Its devices cite 2 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 Dongguan Zsr Biomedical Technology Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Dongguan Zsr Biomedical Technology Company Limited by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FGBUreteroscope And Accessories, Flexible/Rigid1decision
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 20242cite it

What has FDA decided for it lately?

  • K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)Dongguan Zsr Biomedical Technology Company Limited · 2025
  • K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024

All 2 as Dongguan Zsr Biomedical Technology Company Limited →