510(k) · Cleared
ClearedPower Right Angle Linear Cutter Digital Loading Unit with Reloads
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 Nov 7, 2005 as substantially equivalent to K012809 (Power Medical Interventions, Inc., 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 7, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970720 (1997). 7 ancestors in all, the oldest K890841 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 2 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 1 generation backK021701 Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models…Power Medical Interventions, Inc. · 2002 · Recalled
- This deviceK052910 Power Right Angle Linear Cutter Digital Loading Unit with ReloadsPower Medical Interventions, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −2 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −1 | K021701 | Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45… | Power Medical Interventions, Inc. | 2002 | 1 |
| 0 (this device) | K052910 | Power Right Angle Linear Cutter Digital Loading Unit with Reloads | Power Medical Interventions, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K012809 | Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Summary page 1…Staple, Implantable, GDW 3) Predicate Devices: SurgASSIST® Right Angle Linear Cutter Digital Loading Units®, Power Medical Interventions, Inc., K012809. SurgASSIST® Right Angle Linear Cutter Digital Loading Units® with Reloads, Power Medical Interventions, Inc., K… | 2001 |
| * | K021701 | Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60Summary page 1…ical Interventions, Inc., K012809. SurgASSIST® Right Angle Linear Cutter Digital Loading Units® with Reloads, Power Medical Interventions, Inc., K021 70 1. 4) Device Description The device described here isa Power Right Angle Linear Cutter Digital Loading Unit® used… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 5 other devices also cite its predicate K012809.
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 Power Right Angle Linear Cutter Digital Loading Units® have applications in gastrointestinal, gynecological, and general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052910: Power Right Angle Linear Cutter Digital Loading Unit with Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052910
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