FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM— 510(k) K112342
Substantially EquivalentConvatec, Inc.
FDA 510(k) clearance K112342 for FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM, Substantially Equivalent on 2012-04-26. Applicant: Convatec, Inc.. Device class: 2.
Clearance details
- Applicant
- Convatec, Inc.
- 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
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view all- K230400 — Cure Catheter Closed System; Cure Dextra Closed System
- K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
- K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
- K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
- K111365 — VITALA CONTINENCE CONTROL DEVICE
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.