Comfort Sheath Reusable Male External Catheter

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K962384 ↗

FDA Product Code

EXJ

Device Class

Class I

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Uro Tex Urinals

  Class I

  FDA 510(k) K901000 Active Cleared 26 Mar 1990

• Model 820 Top=trak

  Class I

  FDA 510(k) K873039 Active Cleared 11 Feb 1988

• Uro-Tex Male External Catheter

  Class II

  FDA 510(k) K832450 Active Cleared 14 Oct 1983

• Cone Cath

  Class I

  FDA 510(k) K931156 Active Cleared 1 Jul 1993

• Comfort Cath Self Adhering Male External Catheter

  Class I

  FDA 510(k) K934266 Active Cleared 19 Apr 1994

• Comfort Cath Special Self Adhering Male External Catheter

  Class I

  FDA 510(k) K962413 Active Cleared 15 Jul 1996

See all devices from Sierra Laboratories, Inc. →