The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Sureform 60 And Sureform 60 Reloads.
| Device ID | K173721 |
| 510k Number | K173721 |
| Device Name: | SureForm 60 And SureForm 60 Reloads |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Nadine Nasr |
| Correspondent | Nadine Nasr Intuitive Surgical 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 | 2017-12-05 |
| Decision Date | 2018-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874115647 | K173721 | 000 |
| 10886874113858 | K173721 | 000 |
| 10886874113841 | K173721 | 000 |
| 10886874113834 | K173721 | 000 |
| 10886874113827 | K173721 | 000 |