510(k) · Cleared
Recalled · 2009Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)
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 Sep 30, 2003 as substantially equivalent to K003277 (Powermed, Inc., 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 30, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920752 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920752 Endopath Ils Endoscopic Circular StaplerETHICON, Inc. · 1992
- This deviceK032701 Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29…Power Medical Interventions, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK040024 Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29Power Medical Interventions, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K040024Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29Power Medical Interventions, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920752 | Endopath Ils Endoscopic Circular Stapler | ETHICON, Inc. | 1992 | — |
| 0 (this device) | K032701 | Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33) | Power Medical Interventions, Inc. | 2003 | — |
| +1 | K040024 | Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29 | Power Medical Interventions, Inc. | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 15.1 · 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? (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…mm, 25 mm, 29 mm, 33 mm), with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33 (K003277). B. Endopath ILS Endoscopic Circular Staplers, 21 mm, 25 mm, 29 mm, 33 mm, Ethicon Endo-Surgery, Cincinnat… | 2000 |
| * | K920752 | Endopath Ils Endoscopic Circular StaplerSummary page 1…CS29, CS33 (K003277). B. Endopath ILS Endoscopic Circular Staplers, 21 mm, 25 mm, 29 mm, 33 mm, Ethicon Endo-Surgery, Cincinnati, OH. (K920752). 000014 Power Medical Interventions, Inc. SurgA… | 1992 |
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 |
|---|---|---|---|
| K040024 | Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29 | 2004 | 0 |
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-0393-2010 | 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… |
| Nov 20, 2003 | Not classified | Z-0252-04 | Other | improper staple formation or anvil jam |
| Nov 20, 2003 | Not classified | Z-0253-04 | Other | improper staple formation or anvil jam |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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/K032701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032701: Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032701
Report an extraction error
Are you the manufacturer?
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