Data / Medical devices / Sweden / AprioMed AB
AprioMed AB: FDA-registered device maker in Uppsala, Sweden, 3 510(k) clearances
AprioMed AB is registered with the FDA (registration 3007664053) in Uppsala, Sweden. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 27, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007664053
- Address
- Virdings alle 28, Uppsala, Sweden, 754 50
- Owner or operator
- AprioMed AB (9071836)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 29, 2005
- Registered through
- 2027
- Brand names listed
- AprioCore plus, BONOPTY COAXIAL BONE BIOPSY, Bonopty Adapter, Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle, Morrison Steerable Needle, SEESTAR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | 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 |
|---|---|---|---|---|---|---|
| February 27, 2020 | K193268 | APrioCore Plus | KNW | Substantially Equivalent | Apriomed AB | accessdata.fda.gov |
| December 18, 2018 | K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | FCG | Substantially Equivalent | Apriomed AB | accessdata.fda.gov |
| June 9, 2015 | K150625 | Morrison Steerable Needle | KNW | Substantially Equivalent | Apriomed AB | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Biopsy
- All makers of Brace, Drill
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Guide, Needle, Surgical
- All makers of Biopsy Needle
Updated February 27, 2020. 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.