510(k) · Cleared
Recalled · Class II · 2021Endowrist Stapler 45 and Stapler 45 Reloads
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 Jul 25, 2014 after a 143-day review. The FDA summary names its predicate without a number. 3 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 23 times.
- Decided
- Jul 25, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 23
- Predicates
- 0
18 later devices descend from it, 5 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- This deviceK140553 Endowrist Stapler 45 and Stapler 45 ReloadsIntuitive Surgical, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK152421 IS4000 Stapler 30 Instrument and Stapler 30 ReloadsIntuitive Surgical, Inc. · 2016 · Recalled
- Descendant · cites it directly · 12 of its ownK170508 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads…Intuitive Surgical, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsIntuitive Surgical, Inc. · 2016 · cites it directly14descendants
- K170508EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30…Intuitive Surgical, Inc. · 2017 · cites it directly12descendants
- K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · 2 generations on6descendants
- K183224SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · 3 generations on5descendants
- K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140553 | Endowrist Stapler 45 and Stapler 45 Reloads | Intuitive Surgical, Inc. | 2014 | — |
| +1 | K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | Intuitive Surgical, Inc. | 2016 | 3 |
| +1 | K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist… | Intuitive Surgical, Inc. | 2017 | — |
| +2 | K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018 | 3 |
| +3 | K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019 | 1 |
| +2 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 1 |
| 2023 | 2 | 1 |
| 2024 | 2 | 1 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | Intuitive Surgical Endo Wrist Stapler 45 System and Stapler 45 Reloads (for use with da… Named without a submission number | |
| * | — | ENDOPATH ETS Reload (White) Named without a submission number |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | 2016 | 14 |
| K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30… | 2017 | 12 |
| K142683 | 12 mm Endoscopes and Accessories | 2014 | 1 |
| K143217 | 12 mm & Stapler Bladeless Obturators | 2014 | 1 |
| K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30… | 2017 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2021 | Class II | Z-0702-2022 | Nonconforming Material/Component | Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy… |
| Apr 23, 2018 | Class II | Z-2380-2018 | Nonconforming Material/Component | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and… |
| Sep 19, 2017 | Class II | Z-0404-2018 | Process control | Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature… |
| Mar 15, 2017 | Class II | Z-1723-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1721-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1718-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1722-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1724-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1728-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1719-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1720-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1714-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1715-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1717-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1716-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1726-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1727-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1725-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Mar 15, 2017 | Class II | Z-1729-2017 | Device Design | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. |
| Jul 14, 2016 | Class II | Z-2348-2016 | Software design | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend |
| Jul 14, 2016 | Class II | Z-2676-2016 | Nonconforming Material/Component | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening. |
| Jul 14, 2016 | Class II | Z-2675-2016 | Nonconforming Material/Component | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening. |
| May 9, 2016 | Class II | Z-1837-2016 | Manufacturing material removal | Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure. |
The 5 latest of 23 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm…Intuitive Surgical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K152421 (Intuitive Surgical, Inc., 2016) has gone furthest, with 14 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. 2014, 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 Intuitive Surgical Endo Wrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci® Surgical System (Model 1S4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140553 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140553: Endowrist Stapler 45 and Stapler 45 Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140553
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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