510(k) Report

FDA applicant

Zhejiang Yusheng Medical Instrument Co., Ltd.

Zhejiang Province, P.R., CN1 decision2005–20050 recalls

FDA records 1 decision for Zhejiang Yusheng Medical Instrument Co., Ltd. (Zhejiang Province, P.R., CN) in 2005: 1 510(k) clearance. All are in product code HIB (Speculum, Vaginal, Nonmetal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Zhejiang Yusheng Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zhejiang Yusheng Medical Instrument Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zhejiang Yusheng Medical Instrument Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal1decision

What has FDA decided for it lately?

  • K052912Yusheng Disposable Vaginal SpeculumZhejiang Yusheng Medical Instrument Co., Ltd. · 2005

The one decision as Zhejiang Yusheng Medical Instrument Co., Ltd. →