Product Code: LJH FDA class 2 21 CFR 876.5130

System, Irrigation, Urological

Gastroenterology, Urology

A urological irrigation system is a device used to deliver sterile irrigating solutions into the urological tract during endoscopic or surgical procedures of the bladder, ureter, or urethra, maintaining a clear operative field and preventing tissue desiccation and debris accumulation. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LJH and is regulated under 21 CFR 876.5130 within the Gastroenterology and Urology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LJH
Device Class: FDA class 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162992	Karl Storz UROMAT E.A.S.I.	Jul 07, 2017	Substantially Equivalent	Karl Storz Endoscopy America, Inc.
K070873	AMSURE BLADDER IRRIGATION SET	Dec 19, 2007	Substantially Equivalent	Amsino Intl., Inc.
K071832	MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM	Sep 18, 2007	Substantially Equivalent	Medical Scientific, Inc.
K063700	SPYGLASS IRRIGATION SYSTEM	Feb 08, 2007	Substantially Equivalent	Medical Scientific, Inc.
K062551	NEXUS IRRIGATION TUBING SET	Dec 15, 2006	Substantially Equivalent	Nexus Medical, LLC
K042457	URO PRO	Oct 25, 2004	Substantially Equivalent	W.O.M. World of Medicine AG
K040094	PIGGYBACK IRRIGATING SYSTEM	Apr 15, 2004	Substantially Equivalent	Kosin Technologies, LLC
K023808	IRRIGATION SETS	Mar 10, 2003	Substantially Equivalent	International Medsurg Connection
K010607	MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001	Nov 28, 2001	Substantially Equivalent	Benlan, Inc.
K010122	CONTINUOUS FLOW Y-TUBING	Jun 04, 2001	Substantially Equivalent	G.U.-Tek
K001325	FLO ASSISTANT, MODEL 4-250-00	Aug 18, 2000	Substantially Equivalent	Northgate Technologies, Inc.
K990909	MTP UROPUMP DISPOSABLE TUBING SET	Jun 09, 1999	Substantially Equivalent	Mtp Medical Technical Promotion GmbH
K981615	KSEA UROPUMP	Jul 08, 1998	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K980808	ENDO FMS UROLOGY	May 08, 1998	Substantially Equivalent	Future Medical Systems, Inc.
K971982	KARL STORZ MODEL 203020 20 EQUIMAT	Aug 12, 1997	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K970946	MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET	Jun 10, 1997	Substantially Equivalent	Medline Industries, Inc.
K962670	NHMC IRRIGATION TRAY	Aug 14, 1996	Substantially Equivalent	National Healthcare Mfg. Corp.
K960787	TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS	May 14, 1996	Substantially Equivalent	Baxter Healthcare Corp
K943361	NORTHGATE FLOW ASSIST TUBING FOR UROLOGY	Sep 29, 1995	Substantially Equivalent	Northgate Technologies, Inc.
K952583	AQUISEN	Aug 24, 1995	Substantially Equivalent	Aquintel, Inc.
K951569	SURGACTIVATOR	Jun 06, 1995	Substantially Equivalent	Deschutes Medical Products, Inc.
K945140	URO-FLO	Mar 08, 1995	Substantially Equivalent	Mallinckrodt Group, Inc.
K945210	KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP	Feb 07, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K940983	THE KARL STORZ UROMAT(TM)	Sep 20, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K941385	PRO PULSE SYRINGE IRRIGATION SYSTEM	Jun 09, 1994	Substantially Equivalent	Giesy Consultants, Inc.
K882295	FILLING VOLUME OPTION	Sep 13, 1988	Substantially Equivalent	Eris Medical Technology
K832040	STERILE FLUID PRODUCING UNIT #EP550	Sep 29, 1983	Substantially Equivalent	American Cystocope Makers, Inc.
K822743	SOLID STATE CONTINUOUS FLOW CONTROL	Sep 24, 1982	Substantially Equivalent	Widran Urological Group, Ltd.