The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Single-site Permanent Cautery Hook.
| Device ID | K130726 |
| 510k Number | K130726 |
| Device Name: | DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Contact | Melissa S Gonzalez |
| Correspondent | Melissa S Gonzalez INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874113735 | K130726 | 000 |
| 10886874112103 | K130726 | 000 |
| 00886874112090 | K130726 | 000 |