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Aesculap Endoscopic Instruments

by Aesculap, Inc.

510(k) K940936

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 NumberK940936 Date19 Apr 1994ClearedStatusActive

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  • Withdrawn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
GEI
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Aesculap Endoscopic Instruments are devices used in minimally invasive surgical procedures. These instruments are designed for precision and reliability in various surgical applications.

The instruments are supplied non-sterile and are reusable. They are MRI safe and contain no latex. The device is authorized under FDA 510K clearance with product code GEI.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What are Aesculap Endoscopic Instruments used for?

    Aesculap Endoscopic Instruments are used in minimally invasive surgical procedures, designed for precision and reliability across various surgical applications as stated in the device description.

  • Are Aesculap Endoscopic Instruments sterile or non-sterile when supplied?

    The instruments are supplied non-sterile, as specified in the device data, meaning they require sterilization by the user before clinical use.

  • Can Aesculap Endoscopic Instruments be reused after use?

    Yes, the devices are designed for reuse, as explicitly stated in the specifications indicating they are reusable instruments.

  • Are Aesculap Endoscopic Instruments safe for use in MRI environments?

    The instruments are MRI safe, meaning they do not pose a risk or interfere with magnetic resonance imaging procedures when used in or near the scanner.

  • Do Aesculap Endoscopic Instruments contain latex?

    No, the devices contain no latex, making them suitable for patients or staff with latex sensitivities or allergies.