510(k) · Cleared
Clearedda Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Sep 11, 2017 after a 193-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Sep 11, 2017
- Review
- 193 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE…Intuitive Surgical, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da…Intuitive Surgical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK250417 Remanufactured EndoWrist Cobra Grasper (420190)Rebotix · 2025
- Descendant · 2 generations on · 0 of its ownK250539 Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix · 2025
- Descendant · 2 generations on · 0 of its ownK250387 Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix · 2025
- Descendant · 2 generations on · 0 of its ownK250399 Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203632da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X…Intuitive Surgical, Inc. · 2021 · cites it directly6descendants
- K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix · 2025 · 2 generations on0descendants
- K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix · 2025 · 2 generations on0descendants
- K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix · 2025 · 2 generations on0descendants
- K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved… | Intuitive Surgical, Inc. | 2017 | — |
| +1 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X… | Intuitive Surgical, Inc. | 2021 | — |
| +2 | K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | 2025 | — |
| +2 | K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | 2025 | — |
| +2 | K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix | 2025 | — |
| +2 | K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K203632 (Intuitive Surgical, Inc., 2021) has gone furthest, with 6 descendants of its own.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
https://510kreport.com/device/K170644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170644: da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170644
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026