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 Baxter Healthcare Corp.

28
Total
28
Cleared
120d
Avg days
1982
Since

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

28 devices
1–24 of 28
Cleared Jul 07, 2017
Karl Storz UROMAT E.A.S.I.
K162992
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 253d
Cleared Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
K001325
Northgate Technologies, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 08, 1998
KSEA UROPUMP
K981615
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 63d
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 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 Feb 07, 1995
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 105d
Cleared Sep 20, 1994
THE KARL STORZ UROMAT(TM)
K940983
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 203d

About Product Code LJH - Regulatory Context