Data / Medical devices / Denmark / LiNA Medical ApS
LiNA Medical ApS: FDA-registered device maker in Naerum Hovedstaden, Denmark, 8 510(k) clearances
LiNA Medical ApS is registered with the FDA (registration 3027454635) in Naerum Hovedstaden, Denmark. It lists 14 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027454635
- Address
- Naerum Hovedgade 10B, Naerum Hovedstaden, Denmark, 2850
- Owner or operator
- LINA MEDICAL APS (9044000)
- Roles
- Specification developer
- First device listed
- December 29, 2006
- Registered through
- 2026
- Brand names listed
- LiNA CystoVu HD (CYV-100-5; CYV-101-5), LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5), LiNA CystoVu HD Grasper (CYV-GRA-5), LiNA ScopeVu (SCP-100-1), LiNA SeaStar, SS model (4000-S-SS), Skater Fix (8199)
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 22, 2024 | K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | FAJ | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| September 2, 2022 | K221085 | LiNA OperaScope Needle | FBK | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| January 17, 2020 | K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | HIH | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| January 4, 2018 | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | HIH | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| July 24, 2013 | K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | HIN | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| March 11, 2011 | K101458 | LINA XCISE MODEL MOR-1515 | HET | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| October 30, 2007 | K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | KNF | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| December 1, 2006 | K063025 | LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, | GEI | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
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Updated August 22, 2024. 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.