510(k) K032734 ยท KNT Tubes, Gastrointestinal (And Accessories)
CONVATEC FECAL MANAGEMENT SYSTEM
| Applicant | Convatec, A Bristol-Myers Squibb Co., Skillman NJ, US |
| Decision | Substantially Equivalent, Apr 8, 2004 |
| Received | Sep 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2013 | Convatec Inc. ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only
Product Usage:
For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administ Terminated |
KNT | None listed |
| Aug 20, 2013 | Convatec Inc. ConvaTec Flexi-Seal SIGNAL +, Rx Only
Product Usage:
For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. Terminated |
KNT | None listed |
| Dec 30, 2008 | ConvaTec Flexi-Seal Fecal Management System Advanced Odor Control Kit.
Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104
ConvaTec
Skillman, NJ Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.