# K093217: 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jan 21, 2010 after 100 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930667 (1994). 22 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument, Intuitive Surgical, Inc. (2004) Summary page 2.
- K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P, Ethicon Endo-Surgery, Inc. (2004) Summary page 1.

## Most influential descendants
- K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert (2011), 15 descendants of its own
- K143132: IS4000 8mm Harmonic ACE Curved Shears (2015), 9 descendants of its own
- 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

## Recalls of this device
- Jan 16, 2019 · Class II · Z-0841-2019: During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or sm
- Jan 21, 2015 · Class II · Z-1118-2015: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
- Jan 21, 2015 · Class II · Z-1117-2015: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

## Indications for use
The Intuitive Surgical da Vinci Harmonic ACE Device 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 da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GENO4) and Hand Piece (Model HP054).

Source page: https://510kreport.com/device/K093217
Methodology: https://510kreport.com/methodology