FDA.reportPublic FDA data

510(k) K254111

Device
Irrigation/Urology Sets
Applicant
B.Braun Medical, Inc.
510(k) number
K254111
Product code
LJH
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-10
Date received
2025-12-19
Regulation
876.5130
Classification name
System, Irrigation, Urological
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Rachel Pappas
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261670Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 LeadsPoly Medicure Limited2026-10-23
K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.2017-07-07
K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.2007-12-19
K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.2007-09-18
K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.2007-02-08
K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC2006-12-15
K042457URO PROW.O.M. World of Medicine AG2004-10-25
K040094PIGGYBACK IRRIGATING SYSTEMKosin Technologies, LLC2004-04-15
K023808IRRIGATION SETSInternational Medsurg Connection2003-03-10
K010607MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001Benlan, Inc.2001-11-28
K010122CONTINUOUS FLOW Y-TUBINGG.U.-Tek2001-06-04
K001325FLO ASSISTANT, MODEL 4-250-00Northgate Technologies, Inc.2000-08-18
K990909MTP UROPUMP DISPOSABLE TUBING SETMtp Medical Technical Promotion GmbH1999-06-09
K981615KSEA UROPUMPKARL STORZ Endoscopy-America, Inc.1998-07-08
K980808ENDO FMS UROLOGYFuture Medical Systems, Inc.1998-05-08