Data / Medical devices / Switzerland / Oertli Instrumente AG
Oertli Instrumente AG: FDA-registered device maker in BERNECK Sankt Gallen, Switzerland, 2 510(k) clearances
Oertli Instrumente AG is registered with the FDA (registration 8030967) in BERNECK Sankt Gallen, Switzerland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030967
- FEI number
- 1000640985
- Address
- Hafnerwisenstrasse 4, BERNECK Sankt Gallen, Switzerland, CH-9442
- Owner or operator
- OERTLI INSTRUMENTE AG (8030967)
- Roles
- Manufacturer
- First device listed
- November 13, 2014
- Registered through
- 2026
- Brand names listed
- Faros
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 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 |
|---|---|---|---|---|---|---|
| June 27, 2024 | K233398 | Faros Surgical System | HQC | Substantially Equivalent | Oertli Instrumente AG | accessdata.fda.gov |
| August 12, 2014 | K133562 | CATARHEX 3 | HQC | Substantially Equivalent | Oertli Instrumente AG | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Unit, Phacofragmentation
Updated June 27, 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.