FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Spectricept Skin and Wound Cleanser
K Number: K243875
·
Decision Apr 21, 2025
Classifications
1
FEI Numbers
402
Registration Numbers
403
Same Product Code
861
Applicant Total
1
Review Days
125
Basic Information
- Device Name
- Spectricept Skin and Wound Cleanser
- K Number
- K243875
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Antimicrobials, Inc.
- Date Received
- December 17, 2024
- Decision Date
- April 21, 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
Nixall Antimicrobial Solutions Skin & Wound Hydrogel
FDA 510(k)
FDA Unclassified
·Unknown
SiOxC Cream
FDA 510(k)
FDA Unclassified
·Unknown
Sterile Water USP and Sterile 0.9% Normal Saline USP
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Silver Collagen Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Atrauman® Ag
FDA 510(k)
FDA Unclassified
·Unknown