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Slide-On Endosheath System For Sensory Testing

by Vision-Sciences, Inc.

510(k) K031790

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 NumberK031790 Date2 Jul 2003ClearedStatusActive

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  • Withdrawn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, 25 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 Slide-On Endosheath System is a sterile, single-use protective covering for flexible endoscopes. It functions as a physical barrier between the endoscope and the patient during endoscopic examinations of the upper airway, vocal cords, and nasal passages.

This system is designed to reduce patient contact with organic debris and exposure to hazardous chemicals. It is authorized under FDA 510(k) K031790 and serves as an alternative to chemical reprocessing of the endoscope.

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Questions

AI-generated answers, 25 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 primary purpose of the Slide-On Endosheath System?

    This system acts as a physical barrier between a flexible endoscope and the patient. It is designed to reduce patient contact with organic debris and minimize exposure to hazardous chemicals during endoscopic examinations of the nasal passages, vocal cords, and upper airway.

  • Is the Endosheath intended for single-use or reuse?

    The Slide-On Endosheath is a single-use device. It is designed to be disposed of after each patient examination to maintain a sterile barrier and serve as an alternative to the chemical reprocessing of the endoscope itself.

  • What is the regulatory status of this device?

    The Slide-On Endosheath System is authorized under FDA 510(k) number K031790. It is classified as a Class 2 medical device under the regulation number 874.4760.