VITALA CONTINENCE CONTROL DEVICE— 510(k) K111365
Substantially EquivalentConvatec, Inc.
FDA 510(k) clearance K111365 for VITALA CONTINENCE CONTROL DEVICE, Substantially Equivalent on 2011-08-19. Applicant: Convatec, Inc.. Device class: 1.
Clearance details
- Applicant
- Convatec, Inc.
- Product code
- Code EZQ
- Device class
- Class 1
- Regulation
- 21 CFR 876.5900
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skillman, NJ, US
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- K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Adverse events under product code EZQ
product code EZQ- Malfunction
- 800
- Other
- 1
- Total
- 801
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.