Data / Medical devices / Switzerland / Distalmotion SA
Distalmotion SA: FDA-registered device maker in Epalinges Vaud, Switzerland, 2 510(k) clearances
Distalmotion SA is registered with the FDA (registration 3033118964) in Epalinges Vaud, Switzerland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033118964
- Address
- Route de la Corniche 3B, Epalinges Vaud, Switzerland, 1066
- Owner or operator
- Distalmotion SA (10091399)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- November 5, 2024
- Registered through
- 2026
- Brand names listed
- DEXTER ENDOSCOPE ARM, Dexter L6 Accessory Tray, Dexter L6 Bipolar Johann Grasper, Dexter L6 Bipolar Maryland Dissector, Dexter L6 Emergency Release Tool, Dexter L6 Endoscope Cart, Dexter L6 Handle Grip, Dexter L6 Incision Pointer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | SDD | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Software Controlled Endoscope And Instrument Holder | QZB | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| September 30, 2025 | K251197 | Dexter L6 System | SDD | Substantially Equivalent | Distalmotion SA | accessdata.fda.gov |
| August 8, 2024 | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | QZB | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
- All makers of Software Controlled Endoscope And Instrument Holder
Updated September 30, 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.