AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE— 510(k) K123481
Substantially EquivalentConvatec, Inc.
FDA 510(k) clearance K123481 for AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE, Substantially Equivalent on 2013-06-06. 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
- K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
- 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 →
Recalls naming K123481
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123481.
Data sourced from openFDA. This site is unofficial and independent of the FDA.