510(k) Report

FDA applicant

Innovative Surgical Products, Inc.

Mchenry, IL12 decisions1980–19840 recalls

FDA records 12 decisions for Innovative Surgical Products, Inc. (Mchenry, IL) from 1980 to 1984: 12 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Innovative Surgical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Surgical Products, 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?

  • HQCUnit, Phacofragmentation2decisions
  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2decisions
  • GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered2decisions
  • KYBLens, Guide, Intraocular1decision
  • KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration1decision
  • LXPPlug, Scleral1decision

Also: GCX (1), KYG (1), FSE (1).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K840695Phacoemulsification KitsInnovative Surgical Products, Inc. · 19841cites it

What has FDA decided for it lately?

  • K843041Heslin Dispos. Tubing SetInnovative Surgical Products, Inc. · 1984
  • K840693Disposable Scleral Globe PlugInnovative Surgical Products, Inc. · 1984
  • K840695Phacoemulsification KitsInnovative Surgical Products, Inc. · 1984
  • K840694Lens Insertion GlideInnovative Surgical Products, Inc. · 1984
  • K841072Irrigation, Aspiration Tubing SetsInnovative Surgical Products, Inc. · 1984
  • K832235Disposable Vitrectomy HandpieceInnovative Surgical Products, Inc. · 1983
  • K821496Disposable Irriga/Aspir. SystemInnovative Surgical Products, Inc. · 1982
  • K820765Pleural Drainage ReservoirInnovative Surgical Products, Inc. · 1982

All 12 as Innovative Surgical Products, Inc. →