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Galileo High Resolution Micro Coupler

by Netoptix Corp. 510(k)

Active United States

510(k) K971896

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971896 Date10 Oct 1997ClearedStatusActive

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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
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.

The Galileo High Resolution Micro Coupler is a reusable optical interface device designed for use in endoscopic procedures. It functions as a mechanical and optical bridge between an endoscope and a video camera, utilizing internal lenses, prisms, and windows to relay optical images to the camera sensor.

This device is operated by clinical staff in a surgical setting. It has received FDA 510(k) clearance under regulation number 884.1720.

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