The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for E-100 Electrosurgical Generator, Synchroseal.
| Device ID | K191280 |
| 501k Number | K191280 |
| Device Name: | E-100 Electrosurgical Generator, SynchroSeal |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Melissa Gonzalez |
| Correspondent | Melissa Gonzalez Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 501k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-11-14 |