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 |