510(k) · Cleared
Cleared12 mm & Stapler Bladeless Obturators
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 3, 2014 as substantially equivalent to K140553 (Intuitive Surgical, Inc., 2014) after a 23-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Dec 3, 2014
- Review
- 23 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140553 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK140553 Endowrist Stapler 45 and Stapler 45 ReloadsIntuitive Surgical, Inc. · 2014 · Recalled
- This deviceK143217 12 mm & Stapler Bladeless ObturatorsIntuitive Surgical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK170879 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000…Intuitive Surgical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140553 | Endowrist Stapler 45 and Stapler 45 Reloads | Intuitive Surgical, Inc. | 2014 | 23 |
| 0 (this device) | K143217 | 12 mm & Stapler Bladeless Obturators | Intuitive Surgical, Inc. | 2014 | — |
| +1 | K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist… | Intuitive Surgical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K140553 | Endowrist Stapler 45 and Stapler 45 ReloadsSummary page 4…pe and Accessories Product Codes: NAY, GCJ Classification Advisory Committee: General and Plastic Surgery Predicate Device: K140553 - EndoWrist® Stapler 45, Stapler 45 Reloads and Accessories Device Description The subject 12 mm &… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30… | 2017 | 0 |
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?
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 EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143217: 12 mm & Stapler Bladeless Obturators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143217
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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