Self Adhesive Urinary External Cath. W/Remove. Tip

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K881678 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Incare Intermittent Catheter

  Class II

  FDA 510(k) K013345 Active Cleared 7 Jan 2002

• Heelbo Quilted Torso Restraint

  Class I

  FDA 510(k) K963108 Active Cleared 9 Oct 1996

• Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe

  Class II

  FDA 510(k) K013653 Active Cleared 5 Mar 2002

• Incare Pinsite Dressing

  Class I

  FDA 510(k) K905206 Active Cleared 12 Apr 1991

• Checkmate Ankle Restraint System

  Class I

  FDA 510(k) K962963 Active Cleared 24 Oct 1996

• Microgyn II Elec Stim Device Treat of Urin Inconti

  Class II

  FDA 510(k) K891773 Active Cleared 23 Aug 1989

See all devices from Hollister, Inc. →

• What is the device is a self-adhesive urinary external catheter with a removable tip, what is it used for?

  It is used as a collector for urine in indwelling catheter applications, specifically designed for use in gastroenterology and urology settings to manage urinary output non-invasively.

• How is the self-adhesive urinary external catheter with removable tip supplied and by whom?

  It is supplied by Hollister, Inc. as a self-adhesive device with a removable tip, intended for single-patient use in clinical environments requiring urinary collection.

• Is the self-adhesive urinary external catheter with removable tip sterile or single-use?

  While the data does not explicitly state sterility or single-use status, as a Class II device with FDA 510(k) clearance for urinary collection, it is intended for single-patient use to prevent cross-contamination in clinical settings.

• What regulatory pathway was used for the self-adhesive urinary external catheter with removable tip?

  The device received FDA 510(k) clearance under submission K881678, indicating it was found substantially equivalent to a legally marketed predicate device.