# K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 29, 2011 after 23 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: 7 generations back to K930667 (1994). 23 ancestors in all.
15 later devices descend from it; 3 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)
- K093217: 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System), Intuitive Surgical, Inc. (2010) Summary page 1.
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument, Intuitive Surgical, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K191280: E-100 Electrosurgical Generator, SynchroSeal (2019), 4 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

## Indications for use
The da Vinci Harmonic ACE TM 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 da Vinci Surgical Systems (Models ISi200, 1S2000, and 153000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. The Intuitive Surgical HarmonicTM Curved Shears Instrument 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 (Models ISi 200, 1S2000, and 1S3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

Source page: https://510kreport.com/device/K112584
Methodology: https://510kreport.com/methodology