The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Sp Surgical System.
Device ID | K202968 |
510k Number | K202968 |
Device Name: | Da Vinci SP Surgical System |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Contact | Connor Mccarty |
Correspondent | Connor Mccarty Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2020-12-22 |
Summary: | summary |