510(k) · Cleared
Recalled · 2009I45, I45S, I60, and I60S
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 Sep 27, 2007 as substantially equivalent to K003277 (Powermed, Inc., 2000) and 2 other predicates after a 98-day review. Its family tree reaches back 6 generations to 1997. 21 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K970720 (1997). 26 ancestors in all, the oldest K821994 (1982). 21 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 5 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 4 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 3 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 2 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 1 generation backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- This deviceK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- Descendant · 4 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK101797 Sonicision Cordless Ultrasonic Dissection Device Model SCD391…Covidien, Formerly Valleylab, A Division of Tyco · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · cites it directly11descendants
- K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 2 generations on9descendants
- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 3 generations on8descendants
- K160176Signia StaplerCovidien · 2016 · 4 generations on5descendants
- K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco · 2011 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −5 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −4 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −3 | 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 |
| 0 (this device) | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | — |
| +1 | K073001 | Idrives, Idrivec, Idrivef | Power Medical Interventions, Inc. | 2007 | 1 |
| +2 | K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
| +3 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| +4 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| +1 | K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12… | Covidien, Formerly Valleylab, A Division of Tyco | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K003277 | Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33Summary page 1…a) SurgASSIST® System with Circular Stapler Digital Loading Units®. Power Medical Interventions, Inc., Langhorne, PA. (K003277). FRE~ PC100; RCWIOO; FS14, CS21, CS25, CS29, CS33. b) FlexShaft II,Power Medical Intervention… | 2000 |
| * | K021249 | Surgassist Flexshaft 2, Model FS2 14Summary page 1…RE~ PC100; RCWIOO; FS14, CS21, CS25, CS29, CS33. b) FlexShaft II,Power Medical Interventions, Inc., Langhorne, PA. (K021249). RE FS214 C) SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®. Power Medica… | 2002 |
| * | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMSummary page 1…C) SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®. Power Medical Interventions, Inc., Langhorne, PA. (K040720). REF CMLC30, CMLC55, CMLC75. 4) Device Description: The devices described here are reusable i45, i45S, i6O, i60S… | 2004 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073001 | Idrives, Idrivec, Idrivef | 2007 | 11 |
| K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB… | 2011 | 5 |
| K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | 2007 | 1 |
| K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent… | 2009 | 0 |
| K083527 | Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads | 2008 | 0 |
| K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads… | 2008 | 0 |
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-0405-2010 | 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.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K073001 (Power Medical Interventions, Inc., 2007) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K003277.
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 i45, i45S, i60, i60S have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, 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/K071708 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071708: I45, I45S, I60, and I60S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071708
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