LJH · Class II · 21 CFR 876.5130

FDA Product Code LJH: System, Irrigation, Urological

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Northgate Technologies, Inc. and Medical Scientific, Inc..

30
Total
30
Cleared
126d
Avg days
1982
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 211d recently vs 120d historically

FDA 510(k) Cleared System, Irrigation, Urological Devices (Product Code LJH)

30 devices
1–24 of 30
Cleared Oct 23, 2026
Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 )
K261670
Poly Medicure Limited
Gastroenterology & Urology · 156d
Cleared Sep 10, 2026
Irrigation/Urology Sets
K254111
B.Braun Medical, Inc.
Gastroenterology & Urology · 265d
Cleared Jul 07, 2017
Karl Storz UROMAT E.A.S.I.
K162992
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 253d
Cleared Dec 19, 2007
AMSURE BLADDER IRRIGATION SET
K070873
Amsino Intl., Inc.
Gastroenterology & Urology · 265d
Cleared Sep 18, 2007
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
K071832
Medical Scientific, Inc.
Gastroenterology & Urology · 77d
Cleared Feb 08, 2007
SPYGLASS IRRIGATION SYSTEM
K063700
Medical Scientific, Inc.
Gastroenterology & Urology · 57d
Cleared Dec 15, 2006
NEXUS IRRIGATION TUBING SET
K062551
Nexus Medical, LLC
Gastroenterology & Urology · 107d
Cleared Oct 25, 2004
URO PRO
K042457
W.O.M. World of Medicine AG
Gastroenterology & Urology · 45d
Cleared Apr 15, 2004
PIGGYBACK IRRIGATING SYSTEM
K040094
Kosin Technologies, LLC
Gastroenterology & Urology · 90d
Cleared Mar 10, 2003
IRRIGATION SETS
K023808
International Medsurg Connection
Gastroenterology & Urology · 116d
Cleared Nov 28, 2001
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
K010607
Benlan, Inc.
Gastroenterology & Urology · 272d
Cleared Jun 04, 2001
CONTINUOUS FLOW Y-TUBING
K010122
G.U.-Tek
Gastroenterology & Urology · 139d
Cleared Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
K001325
Northgate Technologies, Inc.
Gastroenterology & Urology · 114d
Cleared Jun 09, 1999
MTP UROPUMP DISPOSABLE TUBING SET
K990909
Mtp Medical Technical Promotion GmbH
Gastroenterology & Urology · 83d
Cleared Jul 08, 1998
KSEA UROPUMP
K981615
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 63d
Cleared May 08, 1998
ENDO FMS UROLOGY
K980808
Future Medical Systems, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K971982
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946
Medline Industries, Inc.
Gastroenterology & Urology · 88d
Cleared Aug 14, 1996
NHMC IRRIGATION TRAY
K962670
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 36d
Cleared May 14, 1996
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787
Baxter Healthcare Corp
Gastroenterology & Urology · 78d
Cleared Sep 29, 1995
NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
K943361
Northgate Technologies, Inc.
Gastroenterology & Urology · 443d
Cleared Aug 24, 1995
AQUISEN
K952583
Aquintel, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 06, 1995
SURGACTIVATOR
K951569
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 08, 1995
URO-FLO
K945140
Mallinckrodt Group, Inc.
Gastroenterology & Urology · 139d

About Product Code LJH - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code LJH since 1982, with 30 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LJH Product Code

Recent submissions under LJH have taken an average of 211 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.

LJH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →