510(k) · Cleared
Clearedda Vinci Xi EndoWrist Instruments and Accessories
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. 7 later devices descend from it.
- Decided
- Sep 11, 2017
- Review
- 193 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK170645 da Vinci Xi EndoWrist Instruments and AccessoriesIntuitive 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 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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) | K170645 | da Vinci Xi EndoWrist Instruments and Accessories | 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 | 1 | 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X… | 2021 | 6 |
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/K170645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170645: da Vinci Xi EndoWrist Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170645
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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