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Galileo Endoscopes

by Galileo Electro-Optics Corp. 510(k)

Active United States

510(k) K962116

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962116 Date27 Nov 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Galileo Endoscopes are nasopharyngoscopes (flexible or rigid) used in the ear, nose, and throat medical specialty. They are substantially equivalent devices cleared via the traditional 510(k) pathway.

The device is manufactured by Galileo Electro-Optics Corp. and received FDA 510(k) clearance under K962116 on November 27, 1996. It is supplied as a finished device for use in clinical settings, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.

Other devices from Galileo Electro-Optics Corp.