Data / Medical devices / France / Institut Georges Lopez
Institut Georges Lopez: FDA-registered device maker in Lissieu Auvergne-Rhone-Alpes, France, 5 510(k) clearances
Institut Georges Lopez is registered with the FDA (registration 3010765841) in Lissieu Auvergne-Rhone-Alpes, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010765841
- Address
- Parc tertiaire du Bois Dieu 1 allee des chevreuils, Lissieu Auvergne-Rhone-Alpes, France, 69380
- Owner or operator
- Institut Georges Lopez (10051357)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 7, 2016
- Registered through
- 2026
- Brand names listed
- BEL-GEN Cold Storage Solution, Celsior Cold Flushing, Storage and Transportation Solution for Hearts, DCX Disposable Cassette, P2PC, PCAN, PCL, PEL, PERF-GEN Pulsatile Perfusion Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Line | FKK | 1 | Manufacturer | accessdata.fda.gov |
| Set, Perfusion, Kidney, Disposable | KDL | 2 | Manufacturer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Manufacturer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | 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 |
|---|---|---|---|---|---|---|
| April 25, 2025 | K243998 | DCX Disposable Cassette (DCX) | KDN | Substantially Equivalent | Institut Geroges Lopez | accessdata.fda.gov |
| June 14, 2022 | K221387 | BEL-GEN Cold Storage Solution | KDL | Substantially Equivalent | Institut Georges Lopez | accessdata.fda.gov |
| June 14, 2022 | K221386 | PERF-GEN Pulsatile Perfusion Solution | KDL | Substantially Equivalent | Institut Georges Lopez | accessdata.fda.gov |
| October 15, 2021 | K211224 | RM4 Control Unit | KDN | Substantially Equivalent | Institut Georges Lopez | accessdata.fda.gov |
| August 5, 1999 | K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | MSB | Substantially Equivalent | Sangstat Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Perfusion, Kidney
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of Set, Perfusion, Kidney, Disposable
- All makers of Clamp, Line
Updated April 25, 2025. 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.