# K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 21, 2017 after 29 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 101 ancestors in all.
8 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)
- K140189: Endowrist Vessel Sealer, Intuitive Surgical, Inc. (2014) Summary page 6.
- K143132: IS4000 8mm Harmonic ACE Curved Shears, Intuitive Surgical, Inc. (2015) Summary page 6.
- K152448: da Vinci Single-Site Instrument and Accessories, Intuitive Surgical, Inc. (2016) Summary page 6.

## Most influential descendants
- K173337: Intuitive Surgical EndoWrist Vessel Sealer Extend (2018), 7 descendants of its own
- 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

## Indications for use
The EndoWrist Vessel Sealer 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 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer 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 8 mm Harmonic ACE Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with a compatible da Vinci Surgical System and a compatible Ethicon Endo-Surgery Generator and Hand Piece. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with a compatible da Vinci Surgical System are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

Source page: https://510kreport.com/device/K170865
Methodology: https://510kreport.com/methodology