510(k) Report

FDA applicant

Hunan Handlike Minimally Invasive Surgery Co., Ltd.

Changsha, CN2 decisions2018–20240 recalls

FDA records 2 decisions for Hunan Handlike Minimally Invasive Surgery Co., Ltd. (Changsha, CN) from 2018 to 2024: 2 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, general and plastic surgery panel, where it files most

How often FDA has decided Hunan Handlike Minimally Invasive Surgery Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Hunan Handlike Minimally Invasive Surgery Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 4 predicates; 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.

  • K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2024
  • K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018

All 2 as Hunan Handlike Minimally Invasive Surgery Co., Ltd. →