CONVATEC FECAL MANAGEMENT SYSTEM— 510(k) K032734
Substantially EquivalentConvatec, A Bristol-Myers Squibb Co.
FDA 510(k) clearance K032734 for CONVATEC FECAL MANAGEMENT SYSTEM, Substantially Equivalent on 2004-04-08. Applicant: Convatec, A Bristol-Myers Squibb Co.. Device class: 2.
Clearance details
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skillman, NJ, US
Recent devices under product code KNT
view allMore clearances from Convatec, A Bristol-Myers Squibb Co.
view allAdverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K032734
K-number listed on FDA's recall record- Z-1990-2013 — 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 administer medication.
- Z-1991-2013 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032734.
Data sourced from openFDA. This site is unofficial and independent of the FDA.