510(k) Report

FDA applicant

Jiangsu Kaishou Medical Apparatus Co., Ltd.

Shanghai, CN1 decision2003–20030 recalls

FDA records 1 decision for Jiangsu Kaishou Medical Apparatus Co., Ltd. (Shanghai, CN) in 2003: 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 Jiangsu Kaishou Medical Apparatus Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jiangsu Kaishou Medical Apparatus Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal1decision

What has FDA decided for it lately?

  • K030761Kaishou Vaginal SpeculumJiangsu Kaishou Medical Apparatus Co., Ltd. · 2003

The one decision as Jiangsu Kaishou Medical Apparatus Co., Ltd. →