Data / Medical devices / Germany / Surgvision GMBH
Surgvision GMBH: FDA-registered device maker in Muenchen Bavaria, Germany, 3 510(k) clearances
Surgvision GMBH is registered with the FDA (registration 3026934906) in Muenchen Bavaria, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026934906
- Address
- Kistlerhofstr. 70 (building 79), Muenchen Bavaria, Germany, 81379
- Owner or operator
- SurgVision GmbH (10087568)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 15, 2023
- Registered through
- 2026
- Brand names listed
- EXPLORER AIR II, EXPLORER AIR Sterile Drape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 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 |
|---|---|---|---|---|---|---|
| March 20, 2024 | K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | IZI | Substantially Equivalent | Surgvision GmbH | accessdata.fda.gov |
| February 28, 2023 | K222240 | EXPLORER AIR® II | IZI | Substantially Equivalent | Surgvision GmbH | accessdata.fda.gov |
| February 25, 2022 | K214097 | Explorer Air II | IZI | Substantially Equivalent | Surgvision GmbH | accessdata.fda.gov |
Compare with other makers
Updated March 20, 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.