# K191280: E-100 Electrosurgical Generator, SynchroSeal

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Nov 14, 2019 after 185 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K930667 (1994). 107 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150364: ERBE ESU Model VIO dV with Accessories, Erbe Elektromedizin GmbH (2016) Summary page 6.
- K183107: Intuitive Surgical Vessel Sealer Extend, Intuitive Surgical, Inc. (2018) Summary page 6.

## Most influential descendants
- K223039: da Vinci E-200 Electrosurgical Generator (2022), 3 descendants of its own
- K231212: da Vinci E-200 Electrosurgical Generator (2023), 2 descendants of its own
- K241635: da Vinci E-200 Electrosurgical Generator (2024), 1 descendant of its own
- K253556: da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (2026), 0 descendants of its own

## Recalls of this device
- Jun 22, 2022 · Class II · Z-1484-2022: Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
- Mar 3, 2022 · Class II · Z-1210-2022: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

## Indications for use
SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The E-100 is an electrosurgical generator for use with a compatible da Vinci Surgical System. It is an electrosurgical unit intended to deliver high frequency energy (HF) for cutting, coagulation and vessel sealing of tissues.

Source page: https://510kreport.com/device/K191280
Methodology: https://510kreport.com/methodology