The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Surgical System, Endowrist Instruments And Accessories.
| Device ID | K131861 |
| 510k Number | K131861 |
| Device Name: | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2014-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874115510 | K131861 | 000 |
| 30886874112190 | K131861 | 000 |
| 00886874112229 | K131861 | 000 |
| 00886874112243 | K131861 | 000 |
| 00886874112267 | K131861 | 000 |
| 00886874112274 | K131861 | 000 |
| 00886874112281 | K131861 | 000 |
| 00886874112298 | K131861 | 000 |
| 00886874112304 | K131861 | 000 |
| 00886874112182 | K131861 | 000 |
| 00886874112175 | K131861 | 000 |
| 00886874110355 | K131861 | 000 |
| 00886874110720 | K131861 | 000 |
| 00886874110744 | K131861 | 000 |
| 00886874110898 | K131861 | 000 |
| 00886874112120 | K131861 | 000 |
| 00886874112137 | K131861 | 000 |
| 00886874112144 | K131861 | 000 |
| 00886874112151 | K131861 | 000 |
| 00886874112311 | K131861 | 000 |
| 00886874112328 | K131861 | 000 |
| 00886874112489 | K131861 | 000 |
| 00886874112496 | K131861 | 000 |
| 00886874113905 | K131861 | 000 |
| 00886874114162 | K131861 | 000 |
| 00886874115343 | K131861 | 000 |
| 00886874115374 | K131861 | 000 |
| 00886874115497 | K131861 | 000 |
| 00886874115503 | K131861 | 000 |
| 00886874112465 | K131861 | 000 |
| 00886874112458 | K131861 | 000 |
| 00886874112359 | K131861 | 000 |
| 00886874112366 | K131861 | 000 |
| 00886874112373 | K131861 | 000 |
| 00886874112380 | K131861 | 000 |
| 00886874112397 | K131861 | 000 |
| 00886874112403 | K131861 | 000 |
| 00886874112434 | K131861 | 000 |
| 00886874112441 | K131861 | 000 |
| 00886874110065 | K131861 | 000 |