510(k) · Cleared
Recalled · Class II · 2014Endowrist 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 Aug 29, 2013 as substantially equivalent to K110639 (Intuitive Surgical, Inc., 2011) and 1 other predicate after a 206-day review. Its family tree reaches back 6 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2013
- Review
- 206 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932293 (1994). 23 ancestors in all, the oldest K912544 (1991). 10 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 4 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 3 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 2 generations backK071728 Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2007
- 1 generation backK110639 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2011 · Recalled
- This deviceK130266 Endowrist One Vessel SealerIntuitive Surgical, Inc. · 2013
- 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
- Descendant · 5 generations on · 4 of its ownK191280 E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −5 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −4 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −3 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −2 | K071728 | Modification to: Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2007 | — |
| −1 | K110639 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2011 | 2 |
| 0 (this device) | K130266 | Endowrist One Vessel Sealer | Intuitive Surgical, Inc. | 2013 | — |
| +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 | — |
| +5 | K191280 | E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. | 2019 | 2 |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K110639 | Endowrist One Vessel SealerSummary page 1…NAY Classification: Endoscope and Accessories, 21 CFR 876.1500 Predicate Devices: * Intuitive Surgical's Endo Wrist®One Vessel Sealer(KI 110639) * Ethicon Endo-Surgery's EnSeal PTC (K07 1728) Device Description: The Endo Wrist One Vessel Sealer is an electrosurgi… | 2011 |
| * | K071728 | Modification to: Enseal PTC Tissue Sealing DeviceSummary page 1…and Accessories, 21 CFR 876.1500 Predicate Devices: * Intuitive Surgical's Endo Wrist®One Vessel Sealer(KI 110639) * Ethicon Endo-Surgery's EnSeal PTC (K07 1728) Device Description: The Endo Wrist One Vessel Sealer is an electrosurgical sealing and cuffing instrument to be used in conj… | 2007 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140189 | Endowrist Vessel Sealer | 2014 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2014 | Class II | Z-0063-2015 | Device Design | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K140189 (Intuitive Surgical, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K110639.
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. 2013, 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 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 grasping and blunt dissection of tissue and 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 Endo Wrist 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/K130266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130266: 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/K130266
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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