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Data / Medical devices / Sweden / Bibb Instruments AB

Bibb Instruments AB: FDA-registered device maker in Lund Skane, Sweden, 1 510(k) clearance

Bibb Instruments AB is registered with the FDA (registration 3027641465) in Lund Skane, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3027641465
Address
Medicon Village, SE-223 81, Lund Skane, Sweden, 223 81
Owner or operator
Bibb Instruments AB (10088463)
Roles
Complaint file establishment, Specification developer
First device listed
July 26, 2023
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Biopsy NeedleFCG2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 29, 2023K212423EndoDrill® Model XFCGSubstantially EquivalentBibbinstruments ABaccessdata.fda.gov

Compare with other makers

Updated March 29, 2023. 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.