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Vision Sciences EndoSheath System

by Vision-Sciences, Inc.

510(k) K012543

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 NumberK012543 Date15 Jul 2002ClearedStatusActive

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  • Withdrawn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, 24 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 EndoSheath System is a sterile, disposable protective covering for flexible endoscopes used during examination of the upper airway, vocal chords, and nasal passages. It consists of a sterile, disposable protective sheath that covers the patient-contact portion of flexible ENT scopes.

The device is supplied as a sterile, single-use system for flexible endoscopic examination. It is authorized under FDA 510(k) clearance with product code EOB and is intended for use in Ear, Nose, and Throat procedures. The system includes various model numbers and registration numbers as specified in the authorization documentation.

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