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Modified EndoSheath System for VSI Flexible Cystoscope

by Vision-Sciences, Inc.

510(k) K053560

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 · Special NumberK053560 Date16 Mar 2006ClearedStatusActive

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  • Withdrawn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
FAJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Modified EndoSheath System for VSI Flexible Cystoscope is a protective sheath system designed for use with flexible endoscopes. It covers the entire insertion tube of the flexible cystoscope to provide endoscopic access and examination of the lower urinary tract, including the bladder.

These sterile, single-use systems are available with or without a working channel to facilitate various diagnostic and therapeutic procedures. The device is authorized under FDA 510K and is intended for use in clinical settings such as hospitals and medical practices.

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Questions

AI-generated answers, 21 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 Modified EndoSheath System?

    This system is designed to cover the entire insertion tube of a VSI flexible cystoscope. It provides a protective barrier during endoscopic access and examination of the lower urinary tract, including the bladder.

  • Is this device intended for multiple uses?

    No, the Modified EndoSheath System is a single-use device. It is supplied sterile to ensure patient safety and must be disposed of after a single procedure.

  • Are there different configurations available for this sheath?

    Yes, these systems are available both with and without a working channel. This variety allows clinicians to select the appropriate configuration to facilitate specific diagnostic or therapeutic procedures.

  • What is the regulatory status of this device?

    The Modified EndoSheath System for VSI Flexible Cystoscope is authorized under FDA 510K. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.