The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Probe Holder System.
| Device ID | K071405 |
| 510k Number | K071405 |
| Device Name: | PROBE HOLDER SYSTEM |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Michael H Yramategui |
| Correspondent | Michael H Yramategui INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-10-09 |
| Summary: | summary |