The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endowrist One Vessel Sealer.
| Device ID | K130266 |
| 510k Number | K130266 |
| Device Name: | ENDOWRIST ONE VESSEL SEALER |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Crystal Ong |
| Correspondent | Crystal Ong INTUITIVE SURGICAL, INC. 1266 KIFER RD 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 | 2013-02-04 |
| Decision Date | 2013-08-29 |
| Summary: | summary |