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Medivision Sinoscope

by Medivision Scope Service Center, Inc.

510(k) K971995

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 NumberK971995 Date26 Jun 1997ClearedStatusActive

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  • Withdrawn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
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
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.

The Medivision Sinoscope is a nasopharyngoscope, which is a type of medical device used to visually examine the nasal passages and throat. It is classified as a device with a device class of 2. The device is used in the medical specialty of Ear, Nose, Throat.

The Medivision Sinoscope is supplied with various registration numbers and is regulated under the regulation number 874.4760. It has been authorized with an FDA 510K clearance. The device is associated with multiple fei numbers and product codes, including EOB. It is intended for use in a medical setting, with specific storage and handling requirements.

Other devices from Medivision Scope Service Center, Inc.

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 Medivision Sinoscope used for?

    The Medivision Sinoscope is used to visually examine the nasal passages and throat in a medical setting.

  • Is the Medivision Sinoscope sterile?

    The device data does not specify sterility, but it has specific storage and handling requirements.

  • What is the regulatory classification of the Medivision Sinoscope?

    The Medivision Sinoscope is classified as a device with a device class of 2, regulated under the regulation number 874.4760.