The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Sonicpro Cleaning System, Model 400253.
| Device ID | K073112 |
| 510k Number | K073112 |
| Device Name: | DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 |
| Classification | Washer, Cleaner, Automated, Endoscope |
| 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 | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-08-01 |
| Summary: | summary |