Bard DigniCare Stool Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073598 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The Bard DigniCare Stool Management System is a single-use, latex-free rectal catheter system designed for fecal management in bedridden adult patients. It consists of a retention cuff, a trans-sphincteric zone, and a drainage tube connected to a collection bag.
The device is intended for diverting and collecting liquid or semi-liquid stool to minimize skin contact and provide access for medication administration. It is supplied sterile for single use and was cleared via the FDA 510(k) pathway under K073598.
Frequently asked questions
What is the Bard DigniCare Stool Management System used for?
It is designed for fecal management in bedridden adult patients, specifically to divert and collect liquid or semi-liquid stool to minimize skin contact and provide access for medication administration.
Is the Bard DigniCare Stool Management System sterile and for single use only?
Yes, the device is supplied sterile and intended for single use only, as stated in its description, to reduce infection risk and ensure safe application in clinical settings.
What components make up the Bard DigniCare Stool Management System?
The system consists of a retention cuff, a trans-sphincteric zone, and a drainage tube connected to a collection bag, which work together to manage stool output effectively.
How was the Bard DigniCare Stool Management System cleared for market release?
It was cleared via the FDA 510(k) pathway under submission number K073598, as indicated in the device data, which confirms its regulatory route for U.S. market access.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K073598 FDA 510(k) - BARD DIGNICARE STOOL MANAGEMENT SYSTEM, BARD DIGNICARE STOOL MANAGEMENT SYSTEM - Innolitics, DigniShield™ Stool Management System - BD, PDF JUN 1 3 2008 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073598 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K073598 24 fields · synced Sep 27, 2026