The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for 5 Mm Harmonic Ace Instrument (used With Da Vinci Is1200 & Is2000/is3000 System).
| Device ID | K093217 |
| 510k Number | K093217 |
| Device Name: | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-01-21 |
| Summary: | summary |