510(k) Report

FDA applicant

Horizon Surgical, Inc.

Evergreen, CO1 decision1990–19900 recalls

FDA records 1 decision for Horizon Surgical, Inc. (Evergreen, CO) in 1990: 1 510(k) clearance. All are in product code DSS (Clip, Vascular). 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, cardiovascular panel, where it files most

How often FDA has decided Horizon Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Horizon Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Horizon Surgical, Inc. 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?

  • DSSClip, Vascular1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K901303Horizon Surgical Ligating and Marking ClipHorizon Surgical, Inc. · 19902cite it

What has FDA decided for it lately?

  • K901303Horizon Surgical Ligating and Marking ClipHorizon Surgical, Inc. · 1990

The one decision as Horizon Surgical, Inc. →

Other applicant names beginning “Horizon”

FDA records each applicant name separately; these may or may not be the same firm.

Horizon Medical Products, Inc. 16Horizon Diagnostics, Inc. 7Horizon Medical, Inc. 3Horizon Chemical Co. 1