Medical Device Manufacturer · US , Mchenry , IL

Sierra Laboratories, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1979

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sierra Laboratories, Inc. Gastroenterology & Urology ✕

9 devices

1-9 of 9

Cleared Apr 22, 1997

COMFORT CATH CHOICE MALE EXTERNAL CATHETER

Gastroenterology & Urology · 36d

Cleared Jul 15, 1996

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER

Gastroenterology & Urology · 25d

Cleared Jul 15, 1996

COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER

Gastroenterology & Urology · 24d

Cleared Apr 19, 1994

COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER

Gastroenterology & Urology · 231d

Cleared Jan 07, 1994

ALPINE REUSABLE LEG BAGS

Gastroenterology & Urology · 141d

Cleared Jul 01, 1993

Gastroenterology & Urology · 114d

Cleared Mar 26, 1990

URO TEX URINALS

Gastroenterology & Urology · 24d

Cleared Aug 02, 1988

COMFORT CATH MALE EXTERNAL CATHETER

Gastroenterology & Urology · 14d

Cleared Oct 14, 1983

URO-TEX MALE EXTERNAL CATHETER

Gastroenterology & Urology · 80d