510(k) Report

FDA applicant

Betters (Suzhou) Medical Co., Ltd.

Suzhou, CN2 decisions2023–20230 recalls

FDA records 2 decisions for Betters (Suzhou) Medical Co., Ltd. (Suzhou, CN) in 2023: 2 510(k) clearances. All are in product code NEY (System, Ablation, Microwave And Accessories). 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, general and plastic surgery panel, where it files most

How often FDA has decided Betters (Suzhou) Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Betters (Suzhou) Medical Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Betters (Suzhou) Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NEYSystem, Ablation, Microwave And Accessories2decisions

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.

  • K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)Betters (Suzhou) Medical Co., Ltd. · 20231cites it
  • K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)Betters (Suzhou) Medical Co., Ltd. · 2023
  • K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd. · 2023

All 2 as Betters (Suzhou) Medical Co., Ltd. →