510(k) · Cleared
Recalled · 2009Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM
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 Jun 3, 2004 as substantially equivalent to K020719 (Power Medical Interventions, Inc., 2002) and 2 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1997. 25 later devices descend from it. It has been recalled once.
- Decided
- Jun 3, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K970720 (1997). 24 ancestors in all, the oldest K821994 (1982). 25 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 4 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 3 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 2 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 1 generation backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- This deviceK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004
- Descendant · cites it directly · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
- Descendant · cites it directly · 15 of its ownK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 13 of its ownK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · cites it directly21descendants
- K052415Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · cites it directly15descendants
- K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007 · 2 generations on13descendants
- K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · 2 generations on11descendants
- K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −4 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −3 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −2 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −1 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| 0 (this device) | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | — |
| +1 | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | 1 |
| +1 | K052415 | Power Linear Cutter Reusable Digital Loading Units with Reloads | Power Medical Interventions, Inc. | 2005 | 1 |
| +2 | K063746 | Power Extenders Model# PEC200, PES200,PES200S | Power Medical Interventions, Inc. | 2007 | — |
| +2 | K073001 | Idrives, Idrivec, Idrivef | Power Medical Interventions, Inc. | 2007 | 1 |
| +3 | K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Summary page 1…Reloads, Power Medical Interventions, Inc., New Hope, PA. REF SLC55B, SLCR55B, SLC55G, SLCR55G, SLC30B, SLCR30B, SLC30G, SLCR30G (K020719). b. SurgASSIST® Straight Linear Stapler Digital Loading Units® with Reloads and Straight Linear 4 Row… | 2002 |
| * | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads Cleared while this submission was under review Summary page 1…Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. RE SLS55B, SLSR55B, SLS55G, SLSR55G, SLS55B4, SLSR55B4 (K040398). 000013… | 2004 |
| * | K032696 | Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…Summary page 2…tional 510(k) Premarket Notification - March 17, 2004 c. USSC Auto Suture TA & GIA Staplers, United States Surgical, Norwalk, CT. REF- TA, GIA (K032696). 4) Device Description: The devices described here are reusable CMLC DLUs used in conjunction with a variety of Relo… | 2003 |
What descends from it? (25)
See all 252 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-0398-2010 | 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 7 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K071708 (Power Medical Interventions, Inc., 2007) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K020719.
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® Computer Mediated Linear Cutter Digital Loading Units® have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040720 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040720
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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