Data / Medical devices / Sweden / Abigo Medical AB
Abigo Medical AB: FDA-registered device maker in MOLNDAL Vastra Gotaland, Sweden, 5 510(k) clearances
Abigo Medical AB is registered with the FDA (registration 8043991) in MOLNDAL Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated August 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043991
- FEI number
- 3004017406
- Address
- Molndals Bro 2, MOLNDAL Vastra Gotaland, Sweden, 431 31
- Owner or operator
- ABIGO MEDICAL AB (9004891)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 17, 2007
- Registered through
- 2026
- Brand names listed
- Cutimed Siltec Sorbact B, Cutimed Sorbact Dressing Pad, Cutimed Sorbact Gel, Cutimed Sorbact Ribbon, Cutimed Sorbact Swab, Cutimed Sorbact WCL, Cutimed Sorbion Sorbact, Leukomed Sorbact and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2017 | K171225 | Sorbact Wound Dressing-Ribbon Gauze | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| July 1, 2016 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| January 26, 2015 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) | FRO | Substantially Equivalent | Bsn Medical GmbH | accessdata.fda.gov |
| January 24, 2011 | K100591 | SORBACT | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
| April 19, 2007 | K063059 | SORBACT WOUND DRESSING | FRO | Substantially Equivalent | Abigo Medical AB | accessdata.fda.gov |
Compare with other makers
Updated August 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.