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Van-Tec Modular Flexible Cystourethroscope

by Van-Tec, Inc.

510(k) K870679

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 NumberK870679 Date30 Mar 1987ClearedStatusActive

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  • Withdrawn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
FBO
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 Van-Tec Modular Flexible Cystourethroscope is a cystourethroscope, a type of medical device used for visual examination of the urethra and bladder. It is a flexible device, allowing for navigation through the urinary tract. The device is classified as a Class II device with special controls.

The device is supplied as a modular system and is intended for use in gastroenterology and urology settings. It has been cleared by the FDA with a 510(k) clearance, specifically with the clearance number K870679. The device is stored and used according to standard medical device protocols, with no specific storage or use instructions provided in the device data.

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