FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
K Number: K223526
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
19
Review Days
268
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Basic Information
- Device Name
- ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
- K Number
- K223526
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Medical Limited
- Date Received
- November 23, 2022
- Decision Date
- August 18, 2023
- 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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| K181204 | RENASYS Y-Connector; RENASYS TOUCH | Jan 10, 2019 | Substantially Equivalent |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Aug 21, 2018 | Substantially Equivalent |