Skip to content

Olympus Endoarm

by Olympus Corporation 510(k)

Active United States

510(k) K043128

Overview

Endoscope, Neurological is a floor-standing, gas-powered (compressed nitrogen) stabilizing arm for neuroendoscopes. It provides steady fixation and smooth movement during neurosurgery and spine surgery.

The system includes rigid neuroendoscopes, stabilizing adapter, and camera head (OTV-S7V). It is supplied as a reusable device for use in clinical settings. Authorization is FDA 510(k) clearance under product code GWG and regulation number 882.1480.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043128 Date21 Dec 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Olympus Corp.

See all devices from Olympus Corp. →

Questions

  • What is the Olympus EndoArm used for?

    The Olympus EndoArm is a floor-standing, gas-powered stabilizing arm designed to provide steady fixation and smooth movement of neuroendoscopes during neurosurgery and spine surgery procedures.

  • How is the Olympus EndoArm supplied and is it reusable?

    The Olympus EndoArm is supplied as a reusable device for use in clinical settings, meaning it can be cleaned, sterilized, and used multiple times following appropriate reprocessing protocols.

  • What components are included with the Olympus EndoArm system?

    The system includes rigid neuroendoscopes, a stabilizing adapter, and a camera head (model OTV-S7V), which together enable endoscopic visualization and stabilization during surgical procedures.

  • What regulatory pathway was used for the Olympus EndoArm?

    The Olympus EndoArm received FDA 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device under product code GWG and regulation number 882.1480.