510(k) Report

FDA applicant

Excellent Medical Technology Group Co., Ltd.

Suzhou, CN1 decision2022–20220 recalls

FDA records 1 decision for Excellent Medical Technology Group Co., Ltd. (Suzhou, CN) in 2022: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 Excellent Medical Technology Group Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Excellent Medical Technology Group Co., Ltd. by year, 2022–2026Sources: 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

What has FDA decided for it lately?

  • K220665Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-SterileExcellent Medical Technology Group Co., Ltd. · 2022

The one decision as Excellent Medical Technology Group Co., Ltd. →