The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endowrist Vessel Sealer, 8 Mm Harmonic Ace Curved Shears, Da Vinci Single-site Instruments And Accessories.
| Device ID | K170865 |
| 510k Number | K170865 |
| Device Name: | EndoWrist Vessel Sealer, 8 Mm Harmonic ACE Curved Shears, Da Vinci Single-Site Instruments And Accessories |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Cheryl Wu |
| Correspondent | Cheryl Wu 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 | 2017-03-23 |
| Decision Date | 2017-04-21 |
| Summary: | summary |