510(k) · Cleared
ClearedAmid Stapler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safestitch, LLC · GDW Staple, Implantable
Cleared on Nov 12, 2009 as substantially equivalent to K771177 (United States Surgical, A Division of Tyco Healthc, 1977) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Nov 12, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K771177 (1977). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K120268Amid StaplerSafestich Medical, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771177 | Surgical Stapling Instru., Auto, Suture | United States Surgical, A Division of Tyco Healthc | 1977 | — |
| 0 (this device) | K093253 | Amid Stapler | Safestitch, LLC | 2009 | — |
| +1 | K120268 | Amid Stapler | Safestich Medical, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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 15.0 · 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? (3)
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 |
|---|---|---|---|
| * | K771177 | Surgical Stapling Instru., Auto, SutureSummary page 1…ical Stapler 878.4750 II General and Plastic Surgery GDW AutoSuture Surgical Stapling Instrument, United States Surgical Corporation, a division of Tyco Healthcare X771177) - AutoSuture Disposable Stapling Instrument, United States Surgical Corporation, a division of Tyco Healthcare (K780695) AutoS… | 1977 |
| * | K780695 | Auto Suture Disposable Stapling Instru.Summary page 1…cal Corporation, a division of Tyco Healthcare X771177) - AutoSuture Disposable Stapling Instrument, United States Surgical Corporation, a division of Tyco Healthcare (K780695) AutoSuture Titanium Surgical Staples, United States Surgical Corporation, a division of Tyco Healthcare " (K855047) - The AM… | 1978 |
| * | K855047 | Auto Suture Titanium Surgical StaplesSummary page 1…urgical Corporation, a division of Tyco Healthcare (K780695) AutoSuture Titanium Surgical Staples, United States Surgical Corporation, a division of Tyco Healthcare " (K855047) - The AMID Stapler is a sterile, single use disposable i stapler. The AMID Stapler consists of a manual stapler ; and 17 titan… | 1986 |
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 |
|---|---|---|---|
| K120268 | Amid Stapler | 2012 | 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120268 (Safestich Medical, LLC, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 SafeStitch LLC AMID Stapler & Non-Absorbable Staples has applications in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin.
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/K093253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093253: Amid Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093253
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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