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Storz SLX-F2 Storm Touch

by Karl Storz Endoscopy-America, Inc. 510(k)

Active United States

510(k) K070579

Overview

The Storz SLX-F2 Storm Touch is a lithotriptor device designed for extracorporeal shock-wave applications in urology and gastroenterology. It features a touch panel LCD screen that allows remote control and display communication between the Storz Communication Buss network computer and the SLX-F2 System through a graphic user interface.

The device is supplied as part of the SLX-F2 System and is intended for use in clinical settings. It is a Class II medical device that received FDA 510(k) clearance with the number K070579 on August 30, 2007. The device is manufactured by Karl Storz Endoscopy-America, Inc. and is not described as single-use or reusable in the provided data.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070579 Date30 Aug 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LNS
Device Class
Class II
Regulation
21 CFR Part 876.5990
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the STORZ SLX-F2 Storm Touch used for?

    The STORZ SLX-F2 Storm Touch is a lithotriptor device designed for extracorporeal shock-wave applications specifically in urology and gastroenterology, featuring a touch panel LCD screen for remote control and display communication.

  • How is the STORZ SLX-F2 Storm Touch supplied?

    The device is supplied as part of the SLX-F2 System and is intended for use in clinical settings. It is a Class II medical device that received FDA 510(k) clearance with number K070579 on August 30, 2007.

  • Is the STORZ SLX-F2 Storm Touch single-use or reusable?

    The provided data does not specify whether the STORZ SLX-F2 Storm Touch is designed for single-use or multiple reuse. It is part of the SLX-F2 System intended for clinical use, but no information regarding its disposability or reusability is available.

  • What are the regulatory requirements for the STORZ SLX-F2 Storm Touch?

    The STORZ SLX-F2 Storm Touch is a Class II medical device that received FDA 510(k) clearance with number K070579 on August 30, 2007. It was reviewed by the Gastroenterology and Urology advisory committee and is classified under product code LNS.