510(k) Report

FDA applicant

Changzhou Kangdi Medical Stapler Co., Ltd.

Echo, OR4 decisions2010–20170 recalls

FDA records 4 decisions for Changzhou Kangdi Medical Stapler Co., Ltd. (Echo, OR) from 2010 to 2017: 4 510(k) clearances. All are in product code GDW (Staple, Implantable). Its devices cite 5 predicates, 2 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 Changzhou Kangdi Medical Stapler Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2010: 12012: 12017: 2
2010high 2 (2017) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Changzhou Kangdi Medical Stapler Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GDWStaple, Implantable4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K100723Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5Changzhou Kangdi Medical Stapler Co., Ltd. · 20103cite it
  • K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd. · 20121cites it

What has FDA decided for it lately?

  • K172561Disposable Circular StaplerChangzhou Kangdi Medical Stapler Co., Ltd. · 2017
  • K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd. · 2017
  • K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd. · 2012
  • K100723Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5Changzhou Kangdi Medical Stapler Co., Ltd. · 2010

All 4 as Changzhou Kangdi Medical Stapler Co., Ltd. →