The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Endowrist One Hot Shears Instrument.
| Device ID | K082497 |
| 510k Number | K082497 |
| Device Name: | INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | James Farnworth |
| Correspondent | James Farnworth 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 | 2008-08-29 |
| Decision Date | 2009-05-07 |
| Summary: | summary |