The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Single-site Instrument And Accessories.
| Device ID | K152448 |
| 510k Number | K152448 |
| Device Name: | Da Vinci Single-Site Instrument And Accessories |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Melissa Gonzalez |
| Correspondent | Melissa Gonzalez 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 | 2015-08-27 |
| Decision Date | 2016-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874113790 | K152448 | 000 |
| 00886874113622 | K152448 | 000 |
| 00886874113615 | K152448 | 000 |
| 00886874113608 | K152448 | 000 |
| 00886874113592 | K152448 | 000 |
| 00886874113585 | K152448 | 000 |
| 00886874113561 | K152448 | 000 |
| 00886874113554 | K152448 | 000 |
| 00886874113547 | K152448 | 000 |
| 00886874113639 | K152448 | 000 |
| 00886874113646 | K152448 | 000 |
| 00886874113653 | K152448 | 000 |
| 00886874113752 | K152448 | 000 |
| 00886874113721 | K152448 | 000 |
| 00886874113714 | K152448 | 000 |
| 10886874113704 | K152448 | 000 |
| 00886874113691 | K152448 | 000 |
| 00886874113684 | K152448 | 000 |
| 10886874113674 | K152448 | 000 |
| 00886874113660 | K152448 | 000 |
| 30886874112725 | K152448 | 000 |