The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Da Vinci Si Surgical System: Model Is3000.
| Device ID | K081137 |
| 510k Number | K081137 |
| Device Name: | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2009-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112793 | K081137 | 000 |
| 00886874110478 | K081137 | 000 |
| 00886874110409 | K081137 | 000 |
| 00886874110393 | K081137 | 000 |
| 00886874110386 | K081137 | 000 |
| 00886874110379 | K081137 | 000 |
| 00886874110362 | K081137 | 000 |
| 00886874110348 | K081137 | 000 |
| 00886874110195 | K081137 | 000 |
| 00886874110188 | K081137 | 000 |
| 00886874110683 | K081137 | 000 |
| 00886874110690 | K081137 | 000 |
| 00886874110911 | K081137 | 000 |
| 00886874110874 | K081137 | 000 |
| 00886874110867 | K081137 | 000 |
| 00886874110850 | K081137 | 000 |
| 00886874110799 | K081137 | 000 |
| 00886874110782 | K081137 | 000 |
| 00886874110775 | K081137 | 000 |
| 00886874110751 | K081137 | 000 |
| 00886874110713 | K081137 | 000 |
| 00886874110157 | K081137 | 000 |