Data / Medical devices / Switzerland / LiNA Medical AG
LiNA Medical AG: FDA-registered device maker in Root D4 Luzern, Switzerland, 11 510(k) clearances
LiNA Medical AG is registered with the FDA (registration 3008693678) in Root D4 Luzern, Switzerland. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008693678
- Address
- Platz 3, Root D4 Luzern, Switzerland, 6039
- Owner or operator
- LiNA Medical AG (10033967)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 22, 2010
- Registered through
- 2026
- Brand names listed
- (CYV-100-5; CYV-101-5) LiNA CystoVu HD, (OP-NEE4-6) LiNA OperaScope Needle, (OP-NEE8-6) LiNA OperaScope Needle, (SCP-100-1) LiNA ScopeVu, 35-TV LiNA McCartney tube Transvaginal tube, 45-TV LiNA McCartney tube Transvaginal tube, Hook Forceps, LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5) and more
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 | K221277 | Mygen M-3004 RF Generator M-3004 | GEI | Substantially Equivalent | RF Medical Co., Ltd. | 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 |
| December 11, 2018 | K180999 | Mygen V-1000 RF System | GEI | Substantially Equivalent | RF Medical Co., Ltd. | 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 |
| September 2, 2005 | K051594 | MCCARTNEY ACCESS TUBE | HEW | Substantially Equivalent | Gynetech Pty. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Fluid Drainage Tray
- All makers of Culdoscope (And Accessories)
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Hysteroscope (And Accessories)
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
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.