The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Da Vinci X/xi 8mm Endoscope Plus, 0, Da Vinci X/xi 8mm Endoscope Plus, 30.
| Device ID | K191736 |
| 510k Number | K191736 |
| Device Name: | Da Vinci X/Xi 8mm Endoscope Plus, 0, Da Vinci X/Xi 8mm Endoscope Plus, 30 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Vishal Kanani |
| Correspondent | Vishal Kanani Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874116562 | K191736 | 000 |
| 00886874116555 | K191736 | 000 |