Data / Medical devices / Germany / Intuitive Surgical Optics GmbH
Intuitive Surgical Optics GmbH: FDA-registered device maker in Emmendingen Baden-Wurttemberg, Germany, 2 510(k) clearances
Intuitive Surgical Optics GmbH is registered with the FDA (registration 3017119401) in Emmendingen Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017119401
- Address
- Dammweg 1, Emmendingen Baden-Wurttemberg, Germany, 79312
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- July 31, 2019
- Registered through
- 2026
- Brand names listed
- 8mm Endoscope, 0°, Gen5, 8mm Endoscope, 30°, Gen5, 8mm Hex Cannula, Long, 8mm Hex Cannula, Standard, Blue System Cable, Type B, 7m, CABLE KIT,BLUE FIBERCONNECT,20M, Da Vinci 5 Console - Model: C5000, Da Vinci 5 Robot - Model: R5000 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 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 |
|---|---|---|---|---|---|---|
| March 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 26, 2019 | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Laparoscopic
Updated March 14, 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.