510(k) Report

FDA applicant

Surgica Corp.

El Dorado Hills, CA3 decisions2001–20040 recalls

FDA records 3 decisions for Surgica Corp. (El Dorado Hills, CA) from 2001 to 2004: 3 510(k) clearances. All are in product code HCG (Device, Neurovascular Embolization). Its devices cite 2 predicates, 2 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, neurology panel, where it files most

How often FDA has decided Surgica Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgica Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Surgica Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgica Corp.’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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Which product codes does it file in?

  • HCGDevice, Neurovascular Embolization3decisions

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K001678Pva Foam Embolization ParticlesSurgica Corp. · 20015cite it
  • K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 20023cite it
  • K032619Microstat Pva Foam Embolization ParticlesSurgica Corp. · 20043cite it

What has FDA decided for it lately?

  • K032619Microstat Pva Foam Embolization ParticlesSurgica Corp. · 2004
  • K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002
  • K001678Pva Foam Embolization ParticlesSurgica Corp. · 2001

All 3 as Surgica Corp. →