510(k) · Cleared
Recalled · 2009Idrives, Idrivec, Idrivef
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 Dec 18, 2007 as substantially equivalent to K071708 (Power Medical Interventions, Inc., 2007) and 1 other predicate after a 55-day review. Its family tree reaches back 8 generations to 1997. 11 later devices descend from it. It has been recalled once.
- Decided
- Dec 18, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K970720 (1997). 29 ancestors in all, the oldest K821994 (1982). 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 7 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 6 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 5 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 4 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 3 generations backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- 2 generations backK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- 1 generation backK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- This deviceK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
- Descendant · 2 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- Descendant · 3 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
- Descendant · 4 generations on · 1 of its ownK202864 Tri-Staple 2.0 ReloadsCovidien · 2020
- Descendant · 5 generations on · 0 of its ownK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · cites it directly9descendants
- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 2 generations on8descendants
- K160176Signia StaplerCovidien · 2016 · 3 generations on5descendants
- K202864Tri-Staple 2.0 ReloadsCovidien · 2020 · 4 generations on1descendant
- K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic) · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −7 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −6 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −5 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −4 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| −3 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| −2 | K052415 | Power Linear Cutter Reusable Digital Loading Units with Reloads | Power Medical Interventions, Inc. | 2005 | 1 |
| −1 | K063746 | Power Extenders Model# PEC200, PES200,PES200S | Power Medical Interventions, Inc. | 2007 | — |
| 0 (this device) | K073001 | Idrives, Idrivec, Idrivef | Power Medical Interventions, Inc. | 2007 | — |
| +1 | K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
| +2 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| +3 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| +4 | K202864 | Tri-Staple 2.0 Reloads | Covidien | 2020 | — |
| +5 | K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo… | Covidien (Part of Medtronic) | 2026 | — |
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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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 15.0 · 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 |
|---|---|---|---|
| * | K071708 | I45, I45S, I60, and I60SSummary page 1…ce with integrated controls that operate the DLUs. 5) Device Modification The iDrive functions identically to the predicate devices i45, i45S, i6, i60S (K071708) and the Power Extenders (K063746). The i45, i45S, i60, i60S was modified in order to enable the firing of multipl… | 2007 |
| * | K063746 | Power Extenders Model# PEC200, PES200,PES200SSummary page 1…s: i45, i45S, i60, i60S, Power Medical Interventions, Inc., Langhorne, PA. (KO71708) Power Extenders, Power Medical Interventions, Inc., Langhorne, PA. (K063746) 4) Device Description The iDrive is a reusable, hand-held medical device that is used to operate various SurgA… | 2007 |
What descends from it? (11)
See all 112 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-0406-2010 | 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 10 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K102325 (Covidien, LLC, Formerly Registered AS Tyco Healthca, 2010) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K071708.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 iDriveS/iDriveC/iDriveF, when used with compatible Linear Digital Loading Units®, has 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. The iDriveS/iDriveC/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has…
Read the full statement (97 words)
The iDriveS/iDriveC/iDriveF, when used with compatible Linear Digital Loading Units®, has 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.
The iDriveS/iDriveC/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.
The iDriveS/iDriveC/iDriveF, when used with compatible Circular Digital Loading Units®, has applications for use 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/K073001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073001: Idrives, Idrivec, Idrivef.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073001
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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