The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Is4000 Da Vinci Endowrist Instruments.
| Device ID | K150284 |
| 510k Number | K150284 |
| Device Name: | IS4000 Da Vinci EndoWrist Instruments |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Sarah Rizk |
| Correspondent | Sarah Rizk INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-05 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112410 | K150284 | 000 |
| 00886874112342 | K150284 | 000 |
| 00886874112335 | K150284 | 000 |
| 00886874112250 | K150284 | 000 |
| 00886874112236 | K150284 | 000 |
| 00886874112168 | K150284 | 000 |