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Vision System Colonscope

by Vision-Sciences, Inc.

510(k) K943895

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 NumberK943895 Date3 Feb 1995ClearedStatusActive

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  • Withdrawn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
FDF
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 Vision System Colonscope is a flexible colonoscope and accessory device. It is designed for use in gastroenterology and urology procedures.

This device has received FDA 510(k) clearance. It is regulated under the product code FDF and regulation number 876.1500.

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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 Vision System Colonscope used for?

    The Vision System Colonscope is a flexible colonoscope and accessory device designed for use by clinicians during gastroenterology and urology procedures.

  • Has this device received regulatory clearance?

    Yes, the Vision System Colonscope has received FDA 510(k) clearance. It is regulated under product code FDF and regulation number 876.1500.

  • Which medical specialties is this device intended for?

    This device is intended for use within the fields of gastroenterology and urology, as indicated by its regulatory classification and advisory committee oversight.