510(k) Report

FDA applicant

Max Endoscopy, Inc.

Macedonia, OH2 decisions2008–20090 recalls

FDA records 2 decisions for Max Endoscopy, Inc. (Macedonia, OH) from 2008 to 2009: 2 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and ODC (Endoscope Channel Accessory). 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 Max Endoscopy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Max Endoscopy, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)1decision
  • ODCEndoscope Channel Accessory1decision

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.

  • K083275Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide…Max Endoscopy, Inc. · 20092cite it

What has FDA decided for it lately?

  • K083275Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide…Max Endoscopy, Inc. · 2009
  • K080764Success Cecal Intubation Assist, Model: 4100Max Endoscopy, Inc. · 2008

All 2 as Max Endoscopy, Inc. →