The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intutive Surgical Da Vinci Single Site Instruments And Accessories.
| Device ID | K112208 |
| 510k Number | K112208 |
| Device Name: | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL, INC. 1266 KIFER RD 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 | 2011-08-01 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874117293 | K112208 | 000 |
| 00886874111918 | K112208 | 000 |
| 00886874111970 | K112208 | 000 |
| 00886874111987 | K112208 | 000 |
| 00886874111994 | K112208 | 000 |
| 00886874112007 | K112208 | 000 |
| 00886874112021 | K112208 | 000 |
| 00886874112038 | K112208 | 000 |
| 00886874112045 | K112208 | 000 |
| 00886874112052 | K112208 | 000 |
| 00886874112076 | K112208 | 000 |
| 00886874113479 | K112208 | 000 |
| 00886874111895 | K112208 | 000 |