510(k) · Cleared
Recalled · Class II · 2022SureForm 45, SureForm 45 Reloads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · NAY System, Surgical, Computer Controlled Instrument
Cleared on Jan 18, 2019 as substantially equivalent to K173721 (Intuitive Surgical, 2018) after a 59-day review. Its family tree reaches back 6 generations to 2005. 5 of the 20 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 18, 2019
- Review
- 59 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K051002 (2005). 14 ancestors in all, the oldest K033269 (2003). 5 later devices descend from it, 3 citing it directly. 5 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 5 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 4 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 3 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 2 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 1 generation backK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- This deviceK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019
- Descendant · cites it directly · 4 of its ownK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler…Intuitive Surgical, Inc. · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm…Intuitive Surgical, Inc. · 2023 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK243596 da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm…Intuitive Surgical, Inc. · 2024 · Recalled (Class I)
Class I recalls in this family
- K140560 Echelon Flex Powered Plus Articulating…2 generations back · 2014
- K081146 Echelon Endoscopic Linear Cutters (Articulating…4 generations back · 2008
- K222839 EndoWrist Stapler 30 System, EndoWrist Stapler…cites it directly · 2023
- K211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm…2 generations on · 2021
Most influential descendants
Showing 5 of 5 · See all- K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · cites it directly4descendants
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · 2 generations on2descendants
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm…Intuitive Surgical, Inc. · 2023 · cites it directly1descendant
- K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc. · 2025 · cites it directly0descendants
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −5 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −4 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −3 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −2 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −1 | K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018 | 3 |
| 0 (this device) | K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019 | — |
| +1 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | 2019 | 1 |
| +2 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30… | Intuitive Surgical, Inc. | 2021 | Class I |
| +1 | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System… | Intuitive Surgical, Inc. | 2023 | Class I |
| +1 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 1 |
| 2023 | 1 | 1 |
| 2024 | 1 | 1 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K173721 | SureForm 60 and SureForm 60 ReloadsSummary page 4…plantable Staple Product Codes: NAY (Endoscope and accessories) GDW (Implantable Staple) Predicate Device: SureForm 60 (K173721) Device Description: The Intuitive Surgical SureForm 45 and SureForm 45 Reloads is a disposable surgical stapler system designed… | 2018 |
| † | K053202 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | 2005 |
| † | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD | 2004 |
| † | K170945 | Biodesign Staple Line Reinforcement | 2017 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2022 | Class II | Z-0999-2022 | Under Investigation by firm | As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm… |
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.
- 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
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm…Intuitive Surgical, Inc. · 2023 · Cites it directly · ◆ 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 · 2 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 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K190999 (Intuitive Surgical, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K173721.
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. 2019, 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 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183224: SureForm 45, SureForm 45 Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183224
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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