CONSURE STOOL MANAGEMENT SYSTEM— 510(k) K133465
Substantially EquivalentConsure Medical Pvt , Ltd.
FDA 510(k) clearance K133465 for CONSURE STOOL MANAGEMENT SYSTEM, Substantially Equivalent on 2014-06-26. Applicant: Consure Medical Pvt , Ltd..
Clearance details
- Applicant
- Consure Medical Pvt , Ltd.
- Product code
- Code KNT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.