The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Sp Surgical System, Endowrist Sp Instruments, And Accessories.
| Device ID | K173906 |
| 510k Number | K173906 |
| Device Name: | Da Vinci SP Surgical System, EndoWrist SP Instruments, And Accessories |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Elaine Lee |
| Correspondent | Elaine Lee Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874115671 | K173906 | 000 |
| 00886874113493 | K173906 | 000 |
| 10886874113506 | K173906 | 000 |
| 00886874113516 | K173906 | 000 |
| 00886874114285 | K173906 | 000 |
| 00886874114292 | K173906 | 000 |
| 00886874114308 | K173906 | 000 |
| 00886874114315 | K173906 | 000 |
| 00886874114322 | K173906 | 000 |
| 00886874114339 | K173906 | 000 |
| 10886874114350 | K173906 | 000 |
| 10886874114374 | K173906 | 000 |
| 00886874114384 | K173906 | 000 |
| 00886874114735 | K173906 | 000 |
| 00886874114742 | K173906 | 000 |
| 00886874115190 | K173906 | 000 |
| 00886874115213 | K173906 | 000 |
| 00886874113486 | K173906 | 000 |