510(k) · Cleared
Recalled · 2004Auto Suture Surgical Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GDW Staple, Implantable
Cleared on Dec 19, 2001 as substantially equivalent to K855047 (United States Surgical, A Division of Tyco Healthc, 1986) after a 28-day review. Its family tree reaches back 1 generation to 1986. It has been recalled 8 times.
- Decided
- Dec 19, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K855047 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK855047 Auto Suture Titanium Surgical StaplesUnited States Surgical, A Division of Tyco Healthc · 1986 · Recalled
- This deviceK013860 Auto Suture Surgical StaplesUnited States Surgical, A Division of Tyco Healthc · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K855047 | Auto Suture Titanium Surgical Staples | United States Surgical, A Division of Tyco Healthc | 1986 | 5 |
| 0 (this device) | K013860 | Auto Suture Surgical Staples | United States Surgical, A Division of Tyco Healthc | 2001 | — |
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 GDW? 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 14 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 |
|---|---|---|---|
| * | K855047 | Auto Suture Titanium Surgical StaplesSummary page 1…ster McCoy November 20, 2001 Implantable Staple Impiantable Staple, General and Plastic Surgery Auto Suture* Surgical Staples Auto Suture* Modified Surgical Staples (K855047). The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loa… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2004 | Not classified | Z-0958-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0960-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0961-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0964-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0963-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0959-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0962-04 | Other | Stapler may clamp without the staples being fired into the tissue |
| May 5, 2004 | Not classified | Z-0966-04 | Other | Stapler may clamp without the staples being fired into the tissue |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K855047.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
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/K013860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013860: Auto Suture Surgical Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026