FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Tegaderm Post-Op Transparent Antimicrobial Dressing
K Number: K251866
·
Decision Oct 10, 2025
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
1
Review Days
115
Basic Information
- Device Name
- Tegaderm Post-Op Transparent Antimicrobial Dressing
- K Number
- K251866
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solventum US, LLC
- Date Received
- June 17, 2025
- Decision Date
- October 10, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown