510(k) Report

FDA applicant

American Endoscopy, Inc.

Mchenry, IL19 decisions1982–19852 recalls

FDA records 19 decisions for American Endoscopy, Inc. (Mchenry, IL) from 1982 to 1985: 19 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided American Endoscopy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Endoscopy, Inc. since 2007.

Recalls per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Endoscopy, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like American Endoscopy, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions
  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2decisions
  • KODCatheter, Urological2decisions
  • KNQDilator, Esophageal1decision
  • KTIBronchoscope Accessory1decision
  • FCLForceps, Biopsy, Non-Electric1decision

Also: NVE (1), OCZ (1), ODD (1), GEI (1), GEE (1), GCP (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.

  • K820430Diathermic SnaresAmerican Endoscopy, Inc. · 19822cite it

What has FDA decided for it lately?

  • K853274American Dilatation SystemAmerican Endoscopy, Inc. · 1985
  • K841384Proxima 1 PH MonitorAmerican Endoscopy, Inc. · 1984
  • K833491Endo Bite BlockAmerican Endoscopy, Inc. · 1984
  • K840818Biopsy ForcepsAmerican Endoscopy, Inc. · 1984
  • K833859Tamponade Balloon CuffAmerican Endoscopy, Inc. · 1984
  • K833492Percutaneous Endoscopic GastroscopyAmerican Endoscopy, Inc. · 1983
  • K832458Automatic EndoscopeAmerican Endoscopy, Inc. · 19832 recalls
  • K821818Retrieval BalloonsAmerican Endoscopy, Inc. · 1982

All 19 as American Endoscopy, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K832458ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a…Feb 19, 2010
  • K832458ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer…Sep 11, 2008