510(k) · Cleared
ClearedIdrives, Idrivec, Idrivef with Vascular Indications
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 7, 2007 as substantially equivalent to K071708 (Power Medical Interventions, Inc., 2007) and 2 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Dec 7, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K970720 (1997). 31 ancestors in all, the oldest K821994 (1982). 1 later device descends from it, 1 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 deviceK073148 Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK091215 Intelligent Power Unit, Intelligent Console, Intelligent Delivery…Power Medical Interventions, Inc. · 2009 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc. · 2009 · cites it directly0descendants
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) | K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | Power Medical Interventions, Inc. | 2007 | — |
| +1 | K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System… | Power Medical Interventions, Inc. | 2009 | 1 |
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 | 4 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K071708 | I45, I45S, I60, and I60SSummary page 1…Classification Name: Staple, Implantable, GDW 3) Predicate Devices: * i45, i45S, i60, i60S, Power Medical Interventions, Inc., Langhorne, PA. (K071708) * Power Extenders, Power Medical Interventions, Inc., Langhorne, PA. (K063746) * Right Angle L… | 2007 |
| * | K063746 | Power Extenders Model# PEC200, PES200,PES200SSummary page 1…ower Medical Interventions, Inc., Langhorne, PA. (K071708) * Power Extenders, Power Medical Interventions, Inc., Langhorne, PA. (K063746) * Right Angle Linear Cutter DLUs, 30 mm, 45 mm and 60 mm Vascular, Power Medical Interventions, Inc., La… | 2007 |
| * | K022313 | Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads…Summary page 1…. (K063746) * Right Angle Linear Cutter DLUs, 30 mm, 45 mm and 60 mm Vascular, Power Medical Interventions, Inc., Langhorne, PA. (K022313) 4) Device Description The iDrive is a reusable, hand-held medical device that is used to operate various SurgASS… | 2002 |
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 |
|---|---|---|---|
| K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent… | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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.
- 9 of the 31 ancestors have a recall of any class.
- Of its descendants, K091215 (Power Medical Interventions, Inc., 2009) has gone furthest, with 0 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 Vascular Digital Loading Units®, have applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073148: Idrives, Idrivec, Idrivef with Vascular Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073148
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