510(k) Report

FDA applicant

Shanghai Saints Sages Surgical Co., Ltd.

Shanghai, CN1 decision2025–20250 recalls

FDA records 1 decision for Shanghai Saints Sages Surgical Co., Ltd. (Shanghai, CN) in 2025: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). Its devices cite 2 predicates, 0 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

How often FDA has decided Shanghai Saints Sages Surgical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Shanghai Saints Sages Surgical Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Saints Sages Surgical Co., Ltd.’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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