510(k) Report

FDA applicant

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Changzhou, CN3 decisions2016–20250 recalls

FDA records 3 decisions for Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (Changzhou, CN) from 2016 to 2025: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GDW (Staple, Implantable). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12019: 12025: 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 — Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • GDWStaple, Implantable1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 20194cite it

What has FDA decided for it lately?

  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2019
  • K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2016

All 3 as Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd →