510(k) Report

FDA applicant

American Cystocope Makers, Inc.

Mchenry, IL9 decisions1976–19830 recalls

FDA records 9 decisions for American Cystocope Makers, Inc. (Mchenry, IL) from 1976 to 1983: 9 510(k) clearances. Most are in product codes FAK (Panendoscope (Gastroduodenoscope)) and FGA (Kit, Nephroscope). 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 American Cystocope Makers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Cystocope Makers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Cystocope Makers, 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?

  • FAKPanendoscope (Gastroduodenoscope)1decision
  • FGAKit, Nephroscope1decision
  • OCXEndoscopic Irrigation/Suction System1decision
  • FEHElectrode, Flexible Suction Coagulator1decision
  • FOGHood, Oxygen, Infant1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Also: EOQ (1), FDF (1), LJH (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.

  • K791182Acmi Rigi-Flex NephorscopeAmerican Cystocope Makers, Inc. · 19791cites it
  • K803214Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc. · 19811cites it

What has FDA decided for it lately?

  • K832040Sterile Fluid Producing Unit #EP550American Cystocope Makers, Inc. · 1983
  • K812637Acmi Bipolar Hemostatic SourceAmerican Cystocope Makers, Inc. · 1981
  • K811218Acmi Aspirator Kit #8808American Cystocope Makers, Inc. · 1981
  • K803214Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc. · 1981
  • K791182Acmi Rigi-Flex NephorscopeAmerican Cystocope Makers, Inc. · 1979
  • K770754Duodenoscope, Molel TX-6American Cystocope Makers, Inc. · 1977
  • K760822Model TX-8 PanendoscopeAmerican Cystocope Makers, Inc. · 1976
  • K760451Air Water Source (Acmi Model 710)American Cystocope Makers, Inc. · 1976

All 9 as American Cystocope Makers, Inc. →