The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Is4000 Stapler 45 Instrument And Its Reusable Accessories, Is4000 Endowrist Stapler 30 Instrument, Is3000 Stapler 45 Instrument And Its Reusable Accessories.
| Device ID | K170879 |
| 510k Number | K170879 |
| Device Name: | IS4000 Stapler 45 Instrument And Its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument And Its Reusable Accessories |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Building 101 Sunnyvale, CA 94086 |
| Contact | Kunal Gunjal |
| Correspondent | Kunal Gunjal Intuitive Surgical, Inc. 1266 Kifer Road Building 101 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 | 2017-03-24 |
| Decision Date | 2017-09-21 |
| Summary: | summary |