The following data is part of a premarket notification filed by Intuitive Surgical Inc. with the FDA for Da Vinci Xi Hasson Cone.
| Device ID | K153126 |
| 510k Number | K153126 |
| Device Name: | Da Vinci Xi Hasson Cone |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Vishal Kanani |
| Correspondent | Vishal Kanani 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 | 2015-10-29 |
| Decision Date | 2015-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112656 | K153126 | 000 |