FDA applicant

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Xuchang, CN2 decisions2020–20220 recalls

FDA records 2 decisions for Xuchang Zhengde Environstar Medical Products Co., Ltd. (Xuchang, CN) from 2020 to 2022: 2 510(k) clearances. All are in product code FYA (Gown, Surgical). Its devices cite 2 predicates, 1 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 Xuchang Zhengde Environstar Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Xuchang Zhengde Environstar Medical Products Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xuchang Zhengde Environstar Medical…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Xuchang”

FDA records each applicant name separately; these may or may not be the same firm.

Xuchang Zhengde Environstar Medical Products Co.,L 1

Xuchang Zhengde Environstar Medical Products Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Xuchang”