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 | K141077 |
| 510k Number | K141077 |
| Device Name: | DA VINCI FIREFLY IMAGING SYSTEM |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Melissa S Gonzalez |
| Correspondent | Melissa S Gonzalez INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Product Code | NAY |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | IZI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-04-25 |
| Decision Date | 2014-08-12 |
| Summary: | summary |