510(k) · Cleared
ClearedEndowrist One Suction/Irrigator
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 Aug 26, 2011 as substantially equivalent to K992126 (Circon Corp., 1999) after a 191-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- Aug 26, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934094 (1994). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
- 1 generation backK992126 Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
- This deviceK110451 Endowrist One Suction/IrrigatorIntuitive Surgical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
- Descendant · 2 generations on · 0 of its ownK173415 EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK162973 EndoWrist Suction IrrigatorIntuitive Surgical, Inc. · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014 · cites it directly3descendants
- K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · 2 generations on0descendants
- K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018 · 2 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · 2 generations on0descendants
- K162973EndoWrist Suction IrrigatorIntuitive Surgical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934094 | Stryker Laparoscopic Suction Irrigator | Stryker Corp. | 1994 | 3 |
| −1 | K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation System | Circon Corp. | 1999 | — |
| 0 (this device) | K110451 | Endowrist One Suction/Irrigator | Intuitive Surgical, Inc. | 2011 | — |
| +1 | K123329 | DA Vinvi Surgical System | Intuitive Surgical, Inc. | 2014 | — |
| +2 | K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022 | — |
| +2 | K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | 2018 | — |
| +2 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
| +1 | K162973 | EndoWrist Suction Irrigator | Intuitive Surgical, Inc. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation SystemSummary page 1…urgical, computer controlled instrument Classification: endoscope and accessories, 21 CFR 876.1500, NAY Predicate Device: Surgiflex® WAVE TM Suction-Irrigation System (K9921 26) Device Description: The EndoWrist® One Suction/Irrigator isa single-use, dishosable instrument developed for use with the da Vin… | 1999 |
What descends from it? (5)
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K123329 (Intuitive Surgical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K992126.
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. 2011, 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) | — |
What is it indicated for?
The Endo Wrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110451: Endowrist One Suction/Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110451
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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