510(k) Report

FDA applicant

Jiangmen City Xinhui Baisheng Medical Equipment CO

Jiangmen City, Guangdong, CN2 decisions2009–20100 recalls

FDA records 2 decisions for Jiangmen City Xinhui Baisheng Medical Equipment CO (Jiangmen City, Guangdong, CN) from 2009 to 2010: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 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 Jiangmen City Xinhui Baisheng Medical Equipment CO’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Jiangmen City Xinhui Baisheng Medical Equipment CO by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 6 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.

  • K102372Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DBJiangmen City Xinhui Baisheng Medical Equipment CO · 20101cites it
  • K092634Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO · 20091cites it

What has FDA decided for it lately?

  • K102372Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DBJiangmen City Xinhui Baisheng Medical Equipment CO · 2010
  • K092634Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO · 2009

All 2 as Jiangmen City Xinhui Baisheng Medical Equipment CO →

Other applicant names beginning “Jiangmen”

FDA records each applicant name separately; these may or may not be the same firm.

Jiangmen Sure&Me Medical Product Co., Ltd. 1Jiangmen New Era External Use Drug Co., Ltd. 1Jiangmen Ningrui Medical Supplies Co., Ltd. 1