Data / Medical devices / Sweden / Xaga Surgical AB
Xaga Surgical AB: FDA-registered device maker in Eslov Skane, Sweden, 1 510(k) clearance
Xaga Surgical AB is registered with the FDA (registration 3038611181) in Eslov Skane, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3038611181
- Address
- Akerivagen 17, Eslov Skane, Sweden, SE 241 38
- Owner or operator
- Xaga Surgical AB (10093481)
- Roles
- Manufacturer
- First device listed
- May 22, 2025
- Registered through
- 2026
- Brand names listed
- Forsvall Biopsy Needle System, Forsvall Biopsy Gun, Forsvall Biopsy Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 27, 2025 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | KNW | Substantially Equivalent | Xaga Surgical | accessdata.fda.gov |
Compare with other makers
Updated February 27, 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.