Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K083153 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• 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

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