510(k) Report

FDA applicant

Gri Medical & Electronic Technology Co., Ltd.

Swanee, GA3 decisions2011–20170 recalls

FDA records 3 decisions for Gri Medical & Electronic Technology Co., Ltd. (Swanee, GA) from 2011 to 2017: 3 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 6 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 Gri Medical & Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 22017: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Gri Medical & Electronic Technology Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYAGown, Surgical1decision
  • KKXDrape, Surgical, Antimicrobial1decision
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical GownsGri Medical & Electronic Technology Co., Ltd. · 20112cite it
  • K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. · 20172cite it

What has FDA decided for it lately?

  • K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. · 2017
  • K111458Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment CoversGri Medical & Electronic Technology Co., Ltd. · 2011
  • K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical GownsGri Medical & Electronic Technology Co., Ltd. · 2011

All 3 as Gri Medical & Electronic Technology Co., Ltd. →