510(k) Report

FDA applicant

Omni-Tract Surgical, Div. Minn. Scientific, Inc.

Minneapolis, MN4 decisions1992–20000 recalls

FDA records 4 decisions for Omni-Tract Surgical, Div. Minn. Scientific, Inc. (Minneapolis, MN) from 1992 to 2000: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GAD (Retractor). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Omni-Tract Surgical, Div. Minn. Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omni-Tract Surgical, Div. Minn. Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omni-Tract Surgical, Div. Minn. Scientific, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omni-Tract Surgical, Div. Minn.…’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?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • GADRetractor1decision
  • DWXStripper, Artery, Intraluminal1decision
  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K950214Abdominal Wall RetractorOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 19952cite it

What has FDA decided for it lately?

  • K001339Mri Fastsystem Retractor SystemOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 2000
  • K992583Mass (Micro-Access Spine System)Omni-Tract Surgical, Div. Minn. Scientific, Inc. · 1999
  • K950214Abdominal Wall RetractorOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 1995
  • K913803Intraluminal Artery StripperOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 1992

All 4 as Omni-Tract Surgical, Div. Minn. Scientific, Inc. →

Other applicant names beginning “Omni-Tract”

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

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni Therm, Inc. 5Omni Surgical, L.P. 2Omni-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1