AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER— 510(k) K121275
Substantially EquivalentConvatec, Inc.
FDA 510(k) clearance K121275 for AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER, Substantially Equivalent on 2012-07-25. Applicant: Convatec, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Convatec, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skillman, NJ, US
Recent devices under product code FRO
view allMore clearances from Convatec, Inc.
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
- K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
- K111365 — VITALA CONTINENCE CONTROL DEVICE
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.