510(k) Report

FDA applicant

O.R. Concepts, Inc.

Roanoke, TX34 decisions1986–19943 recalls

FDA records 34 decisions for O.R. Concepts, Inc. (Roanoke, TX) from 1986 to 1994: 34 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). 3 recalls are 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 O.R. Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for O.R. Concepts, Inc. since 2007.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — O.R. Concepts, 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?

  • GCJLaparoscope, General & Plastic Surgery9decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories7decisions
  • GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered2decisions
  • KKXDrape, Surgical, Antimicrobial2decisions
  • KMEBedding, Disposable, Medical1decision
  • GCILaryngoscope, Endoscope1decision

Also: FGS (1), MDM (1), HIG (1), KGX (1), GBZ (1), HIF (1).

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.

  • K932449DR. FOGO.R. Concepts, Inc. · 19932cite it

What has FDA decided for it lately?

  • K941337Flowgun Electrocautery ProbesO.R. Concepts, Inc. · 1994
  • K935970Flowgun Electrocautery Probe HandleO.R. Concepts, Inc. · 1994
  • K935971Flowgun Electrocautery ProbesO.R. Concepts, Inc. · 1994
  • K935645Flowgun Reusable Irrigation ProbesO.R. Concepts, Inc. · 1994
  • K926242Orc Endoscopic Monopolar Electrosurgical ProbeO.R. Concepts, Inc. · 1993
  • K922197Insufflator Tubing KitO.R. Concepts, Inc. · 1993
  • K922244Insufflator Tubing/Filter KitO.R. Concepts, Inc. · 1993
  • K932449DR. FOGO.R. Concepts, Inc. · 19932 recalls

All 34 as O.R. Concepts, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K913500Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection…Jun 3, 2024Class II
  • K932449Dr. Fog Endoscopic fog prevention kit.May 15, 2005
  • K932449Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages.…Apr 30, 2003