The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Bipolar Forceps.
| Device ID | K012833 |
| 510k Number | K012833 |
| Device Name: | INTUITIVE SURGICAL BIPOLAR FORCEPS |
| Classification | System, Surgical, Computer Controlled Instrument |
| 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 | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-11-16 |
| Summary: | summary |