The following data is part of a premarket notification filed by Intuitive Surgical Inc. with the FDA for Da Vinci Firefly Imaging System.
Device ID | K222827 |
510k Number | K222827 |
Device Name: | Da Vinci Firefly Imaging System |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | Intuitive Surgical Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Contact | Melissa Gonzalez |
Correspondent | Melissa Gonzalez Intuitive Surgical Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Product Code | NAY |
Subsequent Product Code | GCJ |
Subsequent Product Code | IZI |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-09-19 |
Decision Date | 2022-10-20 |