Skip to content

Sauer Endoscope Guide and Intubation Aid

by Karl Storz Endoscopy-America, Inc.

510(k) K954125

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954125 Date6 Oct 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Sauer Endoscope Guide and Intubation Aid is a device intended for use in ear, nose, and throat procedures. It is designed to assist in guiding endoscopes and facilitating intubation during airway management.

This device is supplied as a reusable instrument and is indicated for use in clinical settings such as thoracic anesthesia, pediatric airway management, prehospital airway management, and intensive care medicine. It has received FDA 510(k) clearance (K954125) under product code EOQ as a Class II device, cleared via the traditional pathway.

Other devices from Karl Storz Endoscopy-America, Inc.

See all devices from Karl Storz Endoscopy-America, Inc. →

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the Sauer Endoscope Guide and Intubation Aid used for?

    The Sauer Endoscope Guide and Intubation Aid is intended for use in ear, nose, and throat procedures to assist in guiding endoscopes and facilitating intubation during airway management, including applications in thoracic anesthesia, pediatric airway management, prehospital settings, and intensive care medicine.

  • Is the Sauer Endoscope Guide and Intubation Aid reusable or single-use?

    The device is supplied as a reusable instrument, meaning it is designed for multiple uses after appropriate cleaning and reprocessing in accordance with the manufacturer's instructions for use and institutional protocols.

  • How was the Sauer Endoscope Guide and Intubation Aid cleared for market?

    The device received FDA 510(k) clearance under submission number K954125, classified as a Class II device under product code EOQ, and was cleared via the traditional pathway as substantially equivalent to a predicate device.