510(k) · Cleared
Recalled · 2009Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges
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 May 10, 2002 as substantially equivalent to K012809 (Power Medical Interventions, Inc., 2001) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1997. 47 later devices descend from it. It has been recalled once.
- Decided
- May 10, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970720 (1997). 6 ancestors in all, the oldest K890841 (1989). 47 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 1 generation backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- This deviceK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002
- Descendant · cites it directly · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- Descendant · 2 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- Descendant · cites it directly · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · cites it directly46descendants
- K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 2 generations on45descendants
- K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · cites it directly25descendants
- K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · 2 generations on21descendants
- K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −1 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | — |
| +1 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| +2 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| +1 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| +2 | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | 1 |
| +3 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K012809 | Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Summary page 1…NEAR CUTTERS / STAPLING INSTRUMENTS A. SurgASSIST™ System, Right Angle Linear Cutter Digital Loading Unit™. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809). B. EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815). ' 000015… | 2001 |
| * | K980815 | Endopath EZ45 Endoscopic Linear CutterSummary page 1…nit™. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809). B. EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815). ' 000015 Power Medical Interventions, Inc. SurgASSIST™ Straight Linear Cutter DLUs with Blue and Green Reload… | 1998 |
What descends from it? (47)
See all 472 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2009 | Not classified | Z-0396-2010 | 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 5 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K030653 (Power Medical Interventions, Inc., 2003) has gone furthest, with 46 descendants of its own.
- 5 other devices also cite its predicate K012809.
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™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
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/K020719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020719: Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020719
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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