FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
K Number: K123481
·
Decision Jun 6, 2013
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
7
Review Days
205
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Basic Information
- Device Name
- AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
- K Number
- K123481
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convatec, Inc.
- Date Received
- November 13, 2012
- Decision Date
- June 6, 2013
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Convatec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Nov 8, 2023 | Unknown |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Nov 17, 2022 | Substantially Equivalent |
| K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER | Jul 25, 2012 | Substantially Equivalent |
| K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM | Apr 26, 2012 | Substantially Equivalent |
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Aug 19, 2011 | Substantially Equivalent |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Dec 1, 2010 | Substantially Equivalent |