510(k) Report

FDA applicant

Hangzhou Shuyou Medical Instrument Company, Ltd.

West Bloomfield, MI1 decision2005–20050 recalls

FDA records 1 decision for Hangzhou Shuyou Medical Instrument Company, Ltd. (West Bloomfield, MI) in 2005: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 Hangzhou Shuyou Medical Instrument Company, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hangzhou Shuyou Medical Instrument Company, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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