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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | 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 |
|---|---|---|---|---|---|---|
| March 29, 2023 | K212423 | EndoDrill® Model X | FCG | Substantially Equivalent | Bibbinstruments AB | accessdata.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.