# K173337: Intuitive Surgical EndoWrist Vessel Sealer Extend

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 26, 2018 after 185 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K930667 (1994). 102 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories, Intuitive Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K183107: Intuitive Surgical Vessel Sealer Extend (2018), 6 descendants of its own
- K191280: E-100 Electrosurgical Generator, SynchroSeal (2019), 4 descendants of its own
- 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

## Recalls of this device
- Mar 3, 2022 · Class II · Z-1209-2022: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

## Indications for use
The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K173337
Methodology: https://510kreport.com/methodology