The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Da Vinci Surgical System, Model Is1000.
| Device ID | K021036 |
| 510k Number | K021036 |
| Device Name: | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | David Casal |
| Correspondent | David Casal INTUITIVE SURGICAL, INC. 950 KIFER RD. 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 | 2002-04-01 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874111079 | K021036 | 000 |
| 00886874110102 | K021036 | 000 |
| 00886874110096 | K021036 | 000 |