510(k) Report

FDA applicant

Surgivision, Inc.

Houston, TX4 decisions2009–20110 recalls

FDA records 4 decisions for Surgivision, Inc. (Houston, TX) from 2009 to 2011: 4 510(k) clearances. Most are in product codes HCD (Cannula, Ventricular) and HBL (Holder, Head, Neurosurgical (Skull Clamp)). Its devices cite 5 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, neurology panel, where it files most

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

FDA decisions per year

1in 2011

2009: 22010: 12011: 1
2009high 2 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Surgivision, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgivision, Inc.’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?

  • HCDCannula, Ventricular1decision
  • HBLHolder, Head, Neurosurgical (Skull Clamp)1decision
  • KKXDrape, Surgical, Antimicrobial1decision
  • ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K102101Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 20113cite it
  • K091439Head Fixation Arc and Table BaseSurgivision, Inc. · 20091cites it
  • K100836Clearpoint SystemSurgivision, Inc. · 20101cites it

What has FDA decided for it lately?

  • K102101Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 2011
  • K100836Clearpoint SystemSurgivision, Inc. · 2010
  • K091343Mri Neuro DrapeSurgivision, Inc. · 2009
  • K091439Head Fixation Arc and Table BaseSurgivision, Inc. · 2009

All 4 as Surgivision, Inc. →