510(k) Report

FDA applicant

Jiangsu Haize Medical Scientific Development Co., Ltd.

Wuxi, CN2 decisions2016–20230 recalls

FDA records 2 decisions for Jiangsu Haize Medical Scientific Development Co., Ltd. (Wuxi, CN) from 2016 to 2023: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 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 Jiangsu Haize Medical Scientific Development Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Jiangsu Haize Medical Scientific Development Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jiangsu Haize Medical Scientific…’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?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K161421Single Use Surgical Suction IrrigatorJiangsu Haize Medical Scientific Development Co., Ltd. · 20161cites it

What has FDA decided for it lately?

  • K230593VictanJiangsu Haize Medical Scientific Development Co., Ltd. · 2023
  • K161421Single Use Surgical Suction IrrigatorJiangsu Haize Medical Scientific Development Co., Ltd. · 2016

All 2 as Jiangsu Haize Medical Scientific Development Co., Ltd. →