Skip to content

Karl Storz Adult and Pediatric Viscous Fluid Injection Sets

by Karl Storz Endoscopy-America, Inc.

510(k) K950976

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK950976 Date21 Mar 1995ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0572-2024 FDA Class II initiated 24 Oct 2023

    The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

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  • Withdrawn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, 26 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 Karl Storz Adult and Pediatric Viscous Fluid Injection Sets are endoscopic injection needles designed for use in gastroenterology and urology procedures. These sets are intended for the injection of viscous fluids during endoscopic examinations and treatments.

The device is supplied as a Class II medical device under product code FBK with FDA 510(k) clearance K950976. It is available in various models and sizes as indicated by the multiple registration numbers. The device is manufactured by Karl Storz Endoscopy-America, Inc. and is intended for single-use or multiple-use depending on the specific model configuration.

Other devices from Karl Storz Endoscopy-America, Inc.

See all devices from Karl Storz Endoscopy-America, Inc. →

Questions

AI-generated answers, 26 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 are Karl Storz Viscous Fluid Injection Sets used for?

    These are endoscopic injection needles designed specifically for the injection of viscous fluids during gastroenterology and urology procedures. They are used during endoscopic examinations and treatments to deliver therapeutic substances.

  • Are these injection sets single-use or reusable?

    The Karl Storz Viscous Fluid Injection Sets are available in various models, with some designed for single-use and others for multiple-use depending on the specific model configuration. The appropriate usage should be determined based on the model specifications.

  • What sizes and models are available for these injection sets?

    The Karl Storz Viscous Fluid Injection Sets are available in numerous models and sizes as indicated by the multiple registration numbers. Each model is designed to meet specific procedural requirements, and the appropriate selection should be based on clinical needs.

  • What is the regulatory status of these injection sets?

    The Karl Storz Viscous Fluid Injection Sets are supplied as a Class II medical device under product code FBK with FDA 510(k) clearance K950976. This indicates they have been determined to be substantially equivalent to existing devices.