The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Sureform 45 Curved Tip, Sureform 45 Gray Reload.
| Device ID | K190999 |
| 510k Number | K190999 |
| Device Name: | SureForm 45 Curved Tip, SureForm 45 Gray Reload |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Nadine Nasr |
| Correspondent | Nadine Nasr Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-07-12 |