510(k) · Cleared
Recalled · Class I · 2026EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
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 Mar 16, 2023 as substantially equivalent to K170508 (Intuitive Surgical, Inc., 2017) and 4 other predicates after a 177-day review. Its family tree reaches back 9 generations to 2005. 5 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 16, 2023
- Review
- 177 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1 (1 Class I)
- Predicates
- 5
Its longest line of descent runs back 9 generations to K051002 (2005). 17 ancestors in all, the oldest K033269 (2003). 1 later device descends from it, 1 citing it directly. 5 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 5 generations between
- 3 generations backK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
- 2 generations backK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
- 1 generation backK211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler…Intuitive Surgical, Inc. · 2021 · Recalled (Class I)
- This deviceK222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm…Intuitive Surgical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm…Intuitive Surgical, Inc. · 2024 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 8 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 7 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 6 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 5 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 4 generations backK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- 3 generations backK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
- 2 generations backK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
- 1 generation backK211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler…Intuitive Surgical, Inc. · 2021 · Recalled (Class I)
- This deviceK222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm…Intuitive Surgical, Inc. · 2023
Class I recalls in this family
- K211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm…direct predicate · 2021
- K140560 Echelon Flex Powered Plus Articulating…2 generations back · 2014
- K081146 Echelon Endoscopic Linear Cutters (Articulating…4 generations back · 2008
- K241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm…cites it directly · 2024
Most influential descendants
Showing 1 of 1 · See all- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −8 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −7 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −6 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −5 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −4 | 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 |
| −1 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30… | Intuitive Surgical, Inc. | 2021 | Class I |
| 0 (this device) | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System… | Intuitive Surgical, Inc. | 2023 | — |
| +1 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30… | Intuitive Surgical, Inc. | 2024 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 1 |
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.
5 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? (5)
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 |
|---|---|---|---|
| * | K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30…Summary page 5…GAG (Stapler, Surgical) Predicate Device: EndoWrist ™ Stapler 30 Curved-Tip Stapler, EndoWrist Stapler 30 Stapler, EndoWrist Stapler 30 Reloads (K170508) EndoWrist Stapler 45 Stapler, EndoWrist Stapler 45 Curved-Tip Stapler, EndoWrist Stapler 45… | 2017 |
| * | K183224 | SureForm 45, SureForm 45 ReloadsSummary page 5…Stapler 45 Stapler, EndoWrist Stapler 45 Curved-Tip Stapler, EndoWrist Stapler 45 Reloads (K170508) SureForm 45 Staplers and Reloads (K183224 and K190999) SureForm 60 Stapler, SureForm 60 Reloads (K173721) 8 mm SureForm 30 Curved-Tip S… | 2019 |
| * | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray ReloadSummary page 5…tapler, EndoWrist Stapler 45 Curved-Tip Stapler, EndoWrist Stapler 45 Reloads (K170508) SureForm 45 Staplers and Reloads (K183224 and K190999) SureForm 60 Stapler, SureForm 60 Reloads (K173721) 8 mm SureForm 30 Curved-Tip Stapler, 8 mm… | 2019 |
| * | K173721 | SureForm 60 and SureForm 60 ReloadsSummary page 5…doWrist Stapler 45 Reloads (K170508) SureForm 45 Staplers and Reloads (K183224 and K190999) SureForm 60 Stapler, SureForm 60 Reloads (K173721) 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, 8 mm SureForm 30 Reloads (K21… | 2018 |
| * | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsSummary page 5…rm 60 Stapler, SureForm 60 Reloads (K173721) 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, 8 mm SureForm 30 Reloads (K211997) Device Description P a g e |5-2… | 2021 |
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 |
|---|---|---|---|
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads Class I | 2024 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2026 | Class I | Z-1855-2026 | Under Investigation by firm | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
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.
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus…Ethicon Endo-Surgery, LLC · 2014 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 17 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K241638 (Intuitive Surgical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K170508.
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. 2023, 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 a compatible da Vinci Surgical System 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). The Intuitive Surgical EndoWrist Stapler 30…
Read the full statement (269 words)
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System 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).
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
The Intuitive Surgical SureForm 60, SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other Stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.
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/K222839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222839: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222839
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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