# K143132: IS4000 8mm Harmonic ACE Curved Shears

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 2, 2015 after 153 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: 8 generations back to K930667 (1994). 24 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert, Intuitive Surgical, Inc. (2011) Summary page 4.

## Most influential descendants
- K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (2017), 8 descendants of its own
- 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

## Indications for use
The IS4000 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 the IS4000 (da Vinci Xi) Surgical Systems and a compatible Ethicon Endo - Surgery Generator and Hand Piece.

Source page: https://510kreport.com/device/K143132
Methodology: https://510kreport.com/methodology