Data / Medical devices / Bulgaria / Intuitive Surgical Bulgaria EOOD
Intuitive Surgical Bulgaria EOOD: FDA-registered device maker in Parvomay Plovdiv, Bulgaria, 1 510(k) clearance
Intuitive Surgical Bulgaria EOOD is registered with the FDA (registration 3038188839) in Parvomay Plovdiv, Bulgaria. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 26, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038188839
- Address
- 27a Alexandar Stamboliyski Street, Parvomay Plovdiv, Bulgaria, 4270
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- July 31, 2019
- Registered through
- 2027
- Brand names listed
- Da Vinci X/Xi 8mm Endoscope Plus, 0 degree, Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 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
Updated July 26, 2019. 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.