510(k) · Cleared
Recalled · 2009Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument
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 18, 2009 as substantially equivalent to K073001 (Power Medical Interventions, Inc., 2007) and 2 other predicates after a 21-day review. Its family tree reaches back 9 generations to 1997. It has been recalled once.
- Decided
- May 18, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K970720 (1997). 33 ancestors in all, the oldest K821994 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 5 generations between
- 3 generations backK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- 2 generations backK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- 1 generation backK073148 Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
- This deviceK091215 Intelligent Power Unit, Intelligent Console, Intelligent Delivery…Power Medical Interventions, Inc. · 2009
Show all 9 generations
- Root · 9 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 8 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 7 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 6 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 5 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 4 generations backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- 3 generations backK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- 2 generations backK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- 1 generation backK073148 Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
- This deviceK091215 Intelligent Power Unit, Intelligent Console, Intelligent Delivery…Power Medical Interventions, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −8 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −7 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −6 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −5 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| −4 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| −3 | 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 | — |
| −1 | K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | Power Medical Interventions, Inc. | 2007 | — |
| 0 (this device) | K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System… | Power Medical Interventions, Inc. | 2009 | — |
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 | 2 | 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 |
|---|---|---|---|
| * | K073001 | Idrives, Idrivec, Idrivef | 2007 |
| * | K073148 | Idrives, Idrivec, Idrivef with Vascular IndicationsSummary page 2…astomoses between structures. The Drive was previously cleared to market via Ko7300l and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intellig… | 2007 |
| * | K071708 | I45, I45S, I60, and I60S | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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-0409-2010 | 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 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 10 of the 33 ancestors have a recall of any class.
- 1 other device also cites its predicate K073001.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 iDrive Intelligent Power Unit with Console, when used with compatible Intelligent Surgical Instrument Linear Staplers, 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. The iDrive Intelligent Power Unit with [Console, when used with compatible…
Read the full statement (195 words)
The iDrive Intelligent Power Unit with Console, when used with compatible Intelligent Surgical Instrument Linear Staplers, 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.
The iDrive Intelligent Power Unit with [Console, when used with compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.
The iDrive Intelligent Power Unit with iKonsole, when used with compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
The iDrive Intelligent Power Unit with iConsole, when used with compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has 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 buttressing material such as bovine pericardium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091215: Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091215
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