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Endo Fms Urology

by Future Medical Systems, Inc. 510(k)

Active United States

510(k) K980808

Overview

The Endo Fms Urology is a urological irrigation system designed to maintain adequate irrigation pressure and flow during endoscopic procedures. It is indicated for use in endoscopic procedures involving the kidney, ureter, urethra, bladder, and prostate.

This device is authorized under FDA 510(k) clearance K980808. It is classified as a Class II urological irrigation system under product code LJH.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980808 Date8 May 1998ClearedStatusActive

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
LJH
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Endo Fms Urology used for?

    This device is a urological irrigation system indicated for use during endoscopic procedures. It is designed to maintain adequate irrigation pressure and flow when operating within the kidney, ureter, urethra, bladder, and prostate.

  • What is the regulatory status of this device?

    The Endo Fms Urology is authorized under FDA 510(k) clearance K980808. It is classified as a Class II urological irrigation system under product code LJH.

  • Which medical specialty is this device associated with?

    The device is categorized under the Gastroenterology and Urology advisory committees, reflecting its intended use in endoscopic procedures involving the urinary tract.