The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Endowrist Endoscopic Instrument Family.
| Device ID | K013416 |
| 510k Number | K013416 |
| Device Name: | INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Contact | Michael Yramategui |
| Correspondent | Michael Yramategui INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-01-10 |
| Summary: | summary |