Data / Medical devices / Germany / Intuitive Surgical Optics GmbH
Intuitive Surgical Optics GmbH: FDA-registered device maker in Freiburg Baden-Wurttemberg, Germany, 3 510(k) clearances
Intuitive Surgical Optics GmbH is registered with the FDA (registration 3038187466) in Freiburg Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038187466
- Address
- Guerickestrasse 1, Freiburg Baden-Wurttemberg, Germany, 79108
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- July 31, 2019
- Registered through
- 2027
- 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 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 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 |
|---|---|---|---|---|---|---|
| October 14, 2026 | K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| 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 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of System, X-Ray, Angiographic
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Laparoscopic
Updated October 14, 2026. 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.