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InstaFlo Bowel Catheter System Kit

by Hollister, Inc. 510(k)

Active United States

510(k) K100273

Overview

The InstaFlo Bowel Catheter System Kit is a bowel catheter designed for fecal incontinence management. It features a collapse-resistant ring, a low-pressure retention cuff, and a sampling port to facilitate stool sampling while maintaining in-place retention.

This system is intended for single-use and is supplied sterile in a DBM-BAG ONLY configuration. It is regulated under FDA 510K clearance (K100273) and is distributed as part of Hollister’s product line. No additional sterilisation or reprocessing is required before use.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Special NumberK100273 Date22 Apr 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

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Questions

  • What is the InstaFlo Bowel Catheter System Kit specifically designed to manage and how does it differ from standard catheters?

    The InstaFlo Bowel Catheter System Kit is designed specifically for fecal incontinence management, helping patients control bowel movements. It features a collapse-resistant ring to maintain stability inside the bowel, a low-pressure retention cuff to securely hold the catheter in place, and a sampling port for collecting stool samples without dislodging the catheter. This makes it distinct from standard catheters, which lack these retention and sampling features.

  • Is the InstaFlo Bowel Catheter System Kit meant for repeated use, or is it intended to be used only once?

    The InstaFlo Bowel Catheter System Kit is intended for single-use only. It is supplied sterile in a DBM-BAG ONLY configuration, meaning no additional sterilization or reprocessing is required before use. After use, it should be discarded to maintain hygiene and effectiveness.

  • How is the InstaFlo Bowel Catheter System Kit packaged and stored, and what precautions should be taken?

    The kit is supplied sterile in a DBM-BAG ONLY, ensuring it remains uncontaminated until use. Since it is single-use, storage should be in a clean, dry place away from direct sunlight or extreme temperatures. The sealed bag should not be opened until immediately before use to preserve sterility.

  • What regulatory pathway does the InstaFlo Bowel Catheter System Kit follow, and who should clinicians contact for further details?

    The InstaFlo Bowel Catheter System Kit follows the FDA 510(k) clearance pathway, with clearance under K100273. For additional information regarding regulatory status, specifications, or clinical inquiries, clinicians can contact Benjamin Lichtenwalner at Hollister, Inc. via the provided address: 2000 Hollister Dr., Libertyville, IL 60048, US.