Data / Medical devices / Germany / Walz Elektronik GMBH
Walz Elektronik GMBH: FDA-registered device maker in Rohrdorf Baden-Wurttemberg, Germany, 1 510(k) clearance
Walz Elektronik GMBH is registered with the FDA (registration 1000161819) in Rohrdorf Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000161819
- Address
- Walddorfer Strasse 40, Rohrdorf Baden-Wurttemberg, Germany, 72229
- Owner or operator
- Walz Elektronik GmbH (10088634)
- Roles
- Manufacturer
- First device listed
- September 11, 2023
- Registered through
- 2026
- Brand names listed
- electrohydraulic Lithotriptor, sterile EHL-Probes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 31, 2023 | K230488 | EL27-Compact; Sterile EHL-Probes | FFK | Substantially Equivalent | Walz Elektronik GmbH | accessdata.fda.gov |
Compare with other makers
Updated August 31, 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.