510(k) Report

FDA applicant

Top Surgical Manufacturers Co.

Walker, MI12 decisions1983–19850 recalls

FDA records 12 decisions for Top Surgical Manufacturers Co. (Walker, MI) from 1983 to 1985: 12 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

How often FDA has decided Top Surgical Manufacturers Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Top Surgical Manufacturers Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Top Surgical Manufacturers Co. 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?

  • FMFSyringe, Piston3decisions
  • FPASet, Administration, Intravascular2decisions
  • KNZAccessories, A-V Shunt1decision
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision
  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision

Also: FIE (1), GAA (1), FOZ (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.

  • K843414Top Hypodermic Syringe PistonTop Surgical Manufacturers Co. · 19841cites it

What has FDA decided for it lately?

  • K844343Top Single Use U.T.W. a-V Fistula Needle Y TypeTop Surgical Manufacturers Co. · 1985
  • K843415Top Hypodermic Syringe Luer LockTop Surgical Manufacturers Co. · 1984
  • K843313Top Disposable Spinal NeedleTop Surgical Manufacturers Co. · 1984
  • K843414Top Hypodermic Syringe PistonTop Surgical Manufacturers Co. · 1984
  • K841119Tops Dispos. Infusion Set/HemodialysisTop Surgical Manufacturers Co. · 1984
  • K841025Top Disposable Infusion SetTop Surgical Manufacturers Co. · 1984
  • K832624Top Venula I.V. Catheter SetTop Surgical Manufacturers Co. · 1983
  • K832625Top Three Way StopcockTop Surgical Manufacturers Co. · 1983

All 12 as Top Surgical Manufacturers Co. →