Data / Medical devices / Sweden / Suturion AB
Suturion AB: FDA-registered device maker in LUND Skane, Sweden, 2 510(k) clearances
Suturion AB is registered with the FDA (registration 3038138322) in LUND Skane, Sweden. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038138322
- Address
- Scheeleteorget 1, LUND Skane, Sweden, 22363
- Owner or operator
- Suturion AB (10093007)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 17, 2025
- Registered through
- 2026
- Brand names listed
- SutureTOOL, SutureTOOL system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 28, 2025 | K250977 | Suture-TOOL System | NEW | Substantially Equivalent | Suturion AB | accessdata.fda.gov |
| January 22, 2025 | K242835 | Suture-TOOL System | NEW | Substantially Equivalent | Suturion AB | accessdata.fda.gov |
Compare with other makers
Updated April 28, 2025. 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.