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Ureteral Stant Set

by Van-Tec, Inc.

510(k) K820870

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK820870 Date26 Apr 1982ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1347-2009 FDA Unclassified (pre-2012) initiated 18 Mar 2009

    Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

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  • Withdrawn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
FAD
Device Class
Class II
Regulation
21 CFR Part 876.4620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a ureteral stent, as defined by its classification name and device type. It is intended for use in the urinary tract to maintain ureteral patency and facilitate drainage.

It is supplied as a set and has received FDA 510(k) clearance (K820870) under regulation 876.4620. The device is classified as Class II, with product code FAD, and was cleared via the traditional pathway on April 26, 1982.

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Questions

AI-generated answers, 6 Oct 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 Ureteral Stant Set used for?

    The Ureteral Stant Set is intended for use in the urinary tract to maintain ureteral patency and facilitate drainage, as a ureteral stent device.

  • How is the Ureteral Stant Set supplied?

    The device is supplied as a set, meaning it includes all necessary components for ureteral stenting in a single package.

  • What regulatory clearance does the Ureteral Stant Set have?

    The Ureteral Stant Set received FDA 510(k) clearance under K820870, classified as Class II with product code FAD, via the traditional pathway on April 26, 1982.