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

30 devices

25–30 of 30

Cleared Feb 07, 1995

KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 105d

Cleared Sep 20, 1994

THE KARL STORZ UROMAT(TM)

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 203d

Cleared Jun 09, 1994

PRO PULSE SYRINGE IRRIGATION SYSTEM

Giesy Consultants, Inc.

Gastroenterology & Urology · 79d

Cleared Sep 13, 1988

FILLING VOLUME OPTION

Eris Medical Technology

Gastroenterology & Urology · 103d

Cleared Sep 29, 1983

STERILE FLUID PRODUCING UNIT #EP550

American Cystocope Makers, Inc.

Gastroenterology & Urology · 97d

Cleared Sep 24, 1982

SOLID STATE CONTINUOUS FLOW CONTROL

Widran Urological Group, Ltd.

Gastroenterology & Urology · 14d