FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
Antimicrobial Gelling Fiber Dressing with PHMB
K Number: K213473
·
Decision Oct 26, 2023
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
11
Review Days
728
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Basic Information
- Device Name
- Antimicrobial Gelling Fiber Dressing with PHMB
- K Number
- K213473
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Solutions, Ltd.
- Date Received
- October 28, 2021
- Decision Date
- October 26, 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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Other Clearances by Advanced Medical Solutions, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | May 12, 2021 | Substantially Equivalent |
| K190819 | Silicone PHMB Foam Wound Dressing | Jul 25, 2019 | Substantially Equivalent |
| K183645 | Silver High Performance Dressing | May 29, 2019 | Substantially Equivalent |
| K180634 | Surgical Silver Post Operative Dressing | Aug 7, 2018 | Substantially Equivalent |
| K181197 | PHMB Foam Wound Dressing | Aug 3, 2018 | Substantially Equivalent |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | Jul 25, 2017 | Substantially Equivalent |
| K032742 | SILVER FOAM WOUND DRESSING | Aug 16, 2004 | Substantially Equivalent |
| K041316 | ANTIMICROBIAL ALGINATE DRESSING | Aug 5, 2004 | Substantially Equivalent |
| K024298 | ANTIMICROBIAL ALGINATE DRESSING | Jun 30, 2003 | Substantially Equivalent |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Apr 25, 2001 | Substantially Equivalent |