The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Fluorescence Imaging Vision System, Model Ff 100.
| Device ID | K101077 |
| 510k Number | K101077 |
| Device Name: | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | GCJ |
| Subsequent Product Code | IZI |
| Subsequent Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-04-19 |
| Decision Date | 2011-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874110881 | K101077 | 000 |
| 00886874110454 | K101077 | 000 |
| 00886874110447 | K101077 | 000 |
| 00886874110218 | K101077 | 000 |
| 00886874110201 | K101077 | 000 |