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HD Video Rhino Laryngoscope

by Karl Storz Endoscopy-America, Inc. 510(k)

Active United States

510(k) K200740

Overview

The HD Video Rhino Laryngoscope is a nasopharyngoscope designed for the visualization of anatomical structures. It provides high-resolution imaging to assist in the examination of the ear, nose, and throat.

This device is intended for use in ENT outpatient settings and is compatible with KARL STORZ HD camera control units. It features an ergonomic handle with programmable buttons for controlling image and video recording functions.

AI-generated from registry data, 22 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 NumberK200740 Date11 Aug 2020ClearedStatusActive

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
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical use of the HD Video Rhino Laryngoscope?

    This device is a nasopharyngoscope designed to assist clinicians in the visualization of anatomical structures within the ear, nose, and throat during examinations.

  • Is this device compatible with existing imaging equipment?

    Yes, the laryngoscope is specifically designed to be compatible with KARL STORZ HD camera control units to facilitate high-resolution imaging.

  • Does the device offer integrated controls for the clinician?

    Yes, the device features an ergonomic handle equipped with programmable buttons, which allows the user to control image and video recording functions directly during the examination.

  • In what environment is this device intended to be used?

    The HD Video Rhino Laryngoscope is intended for use in ENT outpatient settings, where it supports the visualization needs of medical professionals performing routine examinations.