The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Single-site Wristed Needle Driver.
| Device ID | K141075 |
| 510k Number | K141075 |
| Device Name: | SINGLE-SITE WRISTED NEEDLE DRIVER |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Einav Yemini |
| Correspondent | Einav Yemini INTUITIVE SURGICAL 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 | 2014-04-25 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112113 | K141075 | 000 |