Skip to content

Aesculap Neuroendoscope

by Aesculap, Inc.

510(k) K941239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941239 Date11 Jul 1994ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 19 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 Aesculap Neuroendoscope is a rigid endoscope designed for neurological procedures, specifically for visualizing internal structures within the brain and spinal cord. It falls under the classification of a neurological endoscope, enabling minimally invasive access to complex anatomical regions during neurosurgical interventions.

This device is intended for use in operating rooms under sterile conditions and is supplied as a reusable instrument. It is classified as a Class II medical device under FDA regulations (21 CFR 882.1480) and has received FDA 510(k) clearance (K941239). The neuroendoscope is engineered with angled optics to facilitate visualization of hidden structures without requiring additional incisions or retraction, aiding in procedures such as tumor resection, aneurysm treatment, and other intracranial surgeries.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →