FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SORBACT
K Number: K100591
·
Decision Jan 24, 2011
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
5
Review Days
328
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SORBACT
- K Number
- K100591
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abigo Medical AB
- Date Received
- March 2, 2010
- Decision Date
- January 24, 2011
- 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
Other Clearances by Abigo Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Aug 21, 2017 | Substantially Equivalent |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Jul 1, 2016 | Substantially Equivalent |
| K063059 | SORBACT WOUND DRESSING | Apr 19, 2007 | Substantially Equivalent |
| K920840 | OTOVENT | Oct 5, 1992 | Substantially Equivalent |