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Wiltek Varices Injection Needle

by Wiltek Medical, Inc.

510(k) K894868

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 NumberK894868 Date21 Dec 1989ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 22 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 Wiltek Varices Injection Needle is an endoscopic injection needle used in gastroenterology and urology procedures. It is designed to facilitate the delivery of therapeutic agents through an endoscope.

This device is regulated under FDA 510(k) premarket notification K894868. It is manufactured by Wiltek Medical, Inc. and is classified under regulation number 876.1500.

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Questions

AI-generated answers, 22 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 clinical use for the Wiltek Varices Injection Needle?

    This device is designed for use in gastroenterology and urology procedures to facilitate the delivery of therapeutic agents through an endoscope.

  • How is this device regulated?

    The Wiltek Varices Injection Needle is regulated under FDA 510(k) premarket notification K894868 and is classified under regulation number 876.1500.

  • Who is the manufacturer of this injection needle?

    The device is manufactured by Wiltek Medical, Inc., based in Winston-Salem, North Carolina.