510(k) · Cleared
Recalled · Class II · 2015Endowrist One Vessel Sealer
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 Dec 28, 2011 as substantially equivalent to K012833 (Intuitive Surgical, Inc., 2001) and 1 other predicate after a 299-day review. Its family tree reaches back 5 generations to 1994. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 28, 2011
- Review
- 299 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932293 (1994). 22 ancestors in all, the oldest K912544 (1991). 15 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 4 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 3 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 2 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 1 generation backK071728 Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007
- This deviceK110639 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK130266 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2013 · Recalled
- Descendant · cites it directly · 9 of its ownK140189 Endowrist Vessel SealerIntuitive Surgical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 6 of its ownK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K130266Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2013 · cites it directly10descendants
- K140189Endowrist Vessel SealerIntuitive Surgical, Inc. · 2014 · cites it directly9descendants
- K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc. · 2017 · 2 generations on8descendants
- K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · 3 generations on7descendants
- K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −4 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −3 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −2 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −1 | K071728 | Modification to: Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2007 | — |
| 0 (this device) | K110639 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2011 | — |
| +1 | K130266 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2013 | 1 |
| +1 | K140189 | Endowrist Vessel Sealer | Intuitive Surgical, Inc. | 2014 | 1 |
| +2 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| +3 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | 1 |
| +4 | K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K012833 | Intuitive Surgical Bipolar ForcepsSummary page 1…oduct Code: NAY Classification: Endoscope and accessories, 21 CFR 876.1500 Predicate Devices: Intuitive Surgical EndloWrist Bipolar Instrument (K01 2833) SurgRX, Inc., EnSeal PTC (K071728) Device Description: The EndoWrist One Vessel Sealer is an elect… | 2001 |
| * | K071728 | Modification to: Enseal PTC Tissue Sealing DeviceSummary page 1…pe and accessories, 21 CFR 876.1500 Predicate Devices: Intuitive Surgical EndloWrist Bipolar Instrument (K01 2833) SurgRX, Inc., EnSeal PTC (K071728) Device Description: The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunc… | 2007 |
What descends from it? (15)
See all 153 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2015 | Class II | Z-1141-2015 | Process control | Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws. |
| Jun 8, 2013 | Class II | Z-1689-2013 | Software design | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K130266 (Intuitive Surgical, Inc., 2013) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K012833.
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 EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110639: Endowrist One Vessel Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110639
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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