510(k) Report

FDA applicant

Sie Ltd Surgical Instrument Engineering

Littleton, CO1 decision2006–20060 recalls

FDA records 1 decision for Sie Ltd Surgical Instrument Engineering (Littleton, CO) in 2006: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Sie Ltd Surgical Instrument Engineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sie Ltd Surgical Instrument Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sie Ltd Surgical Instrument Engineering 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?

  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K053511DA Vinci Femtosecond Surgical LaserSie Ltd Surgical Instrument Engineering · 2006

The one decision as Sie Ltd Surgical Instrument Engineering →