510(k) Report

FDA applicant

Suzhou Leapmed Healthcare Corporation

Suzhou, CN4 decisions2021–20220 recalls

FDA records 4 decisions for Suzhou Leapmed Healthcare Corporation (Suzhou, CN) from 2021 to 2022: 4 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FCG (Biopsy Needle). Its devices cite 4 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 Suzhou Leapmed Healthcare Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2021: 12022: 3
2021high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Suzhou Leapmed Healthcare Corporation by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy2decisions
  • FCGBiopsy Needle2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2022
  • K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation · 2022
  • K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation · 2022
  • K212284Disposable Automatic Core Biopsy InstrumentSuzhou Leapmed Healthcare Corporation · 2021

All 4 as Suzhou Leapmed Healthcare Corporation →