GALILEO ENDOSCOPES— 510(k) K962116

Substantially Equivalent

Galileo Electro-Optics Corp.

FDA 510(k) clearance K962116 for GALILEO ENDOSCOPES, Substantially Equivalent on 1996-11-27. Applicant: Galileo Electro-Optics Corp..

Clearance details

Applicant: Galileo Electro-Optics Corp.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1996-05-31
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.