510(k) · Cleared
Clearedda Vinci SP SureForm 45 Staplers and Reloads (SP1098)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GAG Stapler, Surgical
Cleared on Mar 10, 2025 as substantially equivalent to K190999 (Intuitive Surgical, Inc., 2019) and 1 other predicate after a 109-day review. Its family tree reaches back 8 generations to 2005. 2 of the 17 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 10, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K051002 (2005). 16 ancestors in all, the oldest K033269 (2003). No later device cites it as a predicate yet. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK051002 Endopath Endocutter 60 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2005 · Recalled
- 7 generations backK081146 Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · Recalled (Class I)
- 6 generations backK112056 Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T…Ethicon Endo-Surgery, LLC · 2011 · Recalled
- 5 generations backK121600 Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC · 2012
- 4 generations backK140560 Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter…Ethicon Endo-Surgery, LLC · 2014 · Recalled (Class I)
- 3 generations backK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- 2 generations backK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
- 1 generation backK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
- This deviceK243596 da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K051002 | Endopath Endocutter 60 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 2005 | 1 |
| −7 | K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery, LLC | 2008 | Class I |
| −6 | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… | Ethicon Endo-Surgery, LLC | 2011 | 1 |
| −5 | K121600 | Echelon 60 Endoscpic Linear Cutter Reload, White | Ethicon Endo-Surgery, LLC | 2012 | — |
| −4 | K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM… | Ethicon Endo-Surgery, LLC | 2014 | Class I |
| −3 | K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018 | 3 |
| −2 | K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019 | 1 |
| −1 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | 2019 | 1 |
| 0 (this device) | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025 | — |
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 |
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.
2 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 GAG device
- #1 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C)…score 15.7 · 8 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 |
|---|---|---|---|
| * | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray ReloadSummary page 6…510(k) Summary for daVinci SP SureForm 45 Stapler System III. PREDICATE DEVICE INFORMATION Predicate Device: SureForm 45 Curved-Tip Stapler (K190999) SureForm 45 Stapler (K183224) SureForm 45 Reloads (K183224 & K190999) IV.… | 2019 |
| * | K183224 | SureForm 45, SureForm 45 ReloadsSummary page 6…pler System III. PREDICATE DEVICE INFORMATION Predicate Device: SureForm 45 Curved-Tip Stapler (K190999) SureForm 45 Stapler (K183224) SureForm 45 Reloads (K183224 & K190999) IV. Device Description The da Vinci SP SureForm 45 Curve… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 · 3 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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 10 of the 16 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K190999.
How does its category compare?
All GAG devicesGAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GAG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAG
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAG
1,065in 2025
MAUDE reports naming product code GAG, 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 | — | 0 | 919 |
| 2008 | 0 | — | 0 | 366 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 0 | — | 1 | 22 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 49 |
| 2013 | 0 | — | 0 | 135 |
| 2014 | 0 | — | 0 | 302 |
| 2015 | 0 | — | 0 | 144 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 96 |
| 2018 | 0 | — | 1 | 81 |
| 2019 | 0 | — | 0 | 70 |
| 2020 | 0 | — | 0 | 47 |
| 2021 | 0 | — | 0 | 53 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 4 | 102 | 0 | 109 |
| 2024 | 3 | 138 | 0 | 1,126 |
| 2025 | 2 | — | 0 | 1,065 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal 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/K243596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243596: da Vinci SP SureForm 45 Staplers and Reloads (SP1098).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243596
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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