The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Handheld Camera.
| Device ID | K191043 |
| 510k Number | K191043 |
| Device Name: | Da Vinci Handheld Camera |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Manjunath Bisalehalli |
| Correspondent | Manjunath Bisalehalli Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-06-06 |