510(k) Report

FDA applicant

Saphena Medical, Inc.

Mission Viejo, CA1 decision2014–20141 recall

FDA records 1 decision for Saphena Medical, Inc. (Mission Viejo, CA) in 2014: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Saphena Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2014high 1 (2024) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Saphena Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc. · 20141 recall

The one decision as Saphena Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140603Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally…Sep 17, 2024Class II