510(k) · Cleared
Recalled · 2009Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Power Medical Interventions, Inc. · GDW Staple, Implantable
Cleared on Feb 4, 2004 as substantially equivalent to K003277 (Powermed, Inc., 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.
- Decided
- Feb 4, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920752 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK920752 Endopath Ils Endoscopic Circular StaplerETHICON, Inc. · 1992
- 1 generation backK032701 Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29…Power Medical Interventions, Inc. · 2003 · Recalled
- This deviceK040024 Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29Power Medical Interventions, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920752 | Endopath Ils Endoscopic Circular Stapler | ETHICON, Inc. | 1992 | — |
| −1 | K032701 | Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33) | Power Medical Interventions, Inc. | 2003 | 3 |
| 0 (this device) | K040024 | Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29 | Power Medical Interventions, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K003277 | Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33Summary page 1…oading Units®, (2] mm, 25 mm, 29 mm, 33 mm), with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. FR-EF CS21, CS25, CS29, CS33 (K003277 and K032701), 4) Device Description: The SurgASSIST® Circular Stapler Digital Loading Units® (DLUs) offer computer medi… | 2000 |
| * | K032701 | Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)Summary page 1…®, (2] mm, 25 mm, 29 mm, 33 mm), with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. FR-EF CS21, CS25, CS29, CS33 (K003277 and K032701), 4) Device Description: The SurgASSIST® Circular Stapler Digital Loading Units® (DLUs) offer computer mediated steerin… | 2003 |
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 |
|---|---|---|---|---|
| Sep 23, 2009 | Not classified | Z-0401-2010 | Nonconforming Material/Component | Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 6 other devices also cite its predicate K003277.
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 SurgASSIST® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040024: Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040024
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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