510(k) · Cleared
ClearedAuto Suture Poly Gia Surgical Stapler
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 Oct 31, 1984 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 31, 1984
- Review
- 72 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK843603 Auto Suture Poly Gia Surgical StaplerUnited States Surgical, A Division of Tyco Healthc · 1984
- Descendant · cites it directly · 6 of its ownK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- Descendant · 2 generations on · 5 of its ownK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- Descendant · 3 generations on · 1 of its ownK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK062008 Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004 · cites it directly6descendants
- K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004 · 2 generations on5descendants
- K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005 · 2 generations on2descendants
- K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025 · 3 generations on1descendant
- K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K843603 | Auto Suture Poly Gia Surgical Stapler | United States Surgical, A Division of Tyco Healthc | 1984 | — |
| +1 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +2 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +2 | K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2005 | — |
| +3 | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| +3 | K062008 | Endo Car Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041751 (Niti Medical Technologies, Ltd., 2004) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/K843603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K843603: Auto Suture Poly Gia Surgical Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843603
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026