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Esophagoscope and Accessories

by Karl Storz Endoscopy-America, Inc.

510(k) K943667

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943667 Date18 Aug 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
EOX
Device Class
Class II
Regulation
21 CFR Part 874.4710
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

An esophagoscope (flexible or rigid) is a device intended for visual examination and treatment of the esophagus. It may be used with accessories such as light sources, biopsy forceps, and suction tubes to support diagnostic and therapeutic procedures.

This device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization. It is used in clinical settings for ear, nose, and throat (ENT) procedures and is authorized under FDA 510(k) clearance K943667. The device is classified as Class II under regulation number 874.4710.

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Questions

AI-generated answers, 23 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 esophagoscope and accessories used for?

    The esophagoscope is intended for visual examination and treatment of the esophagus and may be used with accessories like light sources, biopsy forceps, and suction tubes to support diagnostic and therapeutic procedures in ENT clinical settings.

  • Is the esophagoscope supplied sterile or non-sterile, and is it for single use or reuse?

    The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization, as stated in the device description, making it suitable for multiple procedures when properly reprocessed.

  • What regulatory authorization does the esophagoscope have?

    The esophagoscope and accessories are authorized under FDA 510(k) clearance K943667, classified as Class II under regulation number 874.4710, with a traditional clearance decision based on substantial equivalence.