510(k) · Cleared
ClearedSurgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V & RALC60V
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 9, 2002 as substantially equivalent to K021701 (Power Medical Interventions, Inc., 2002) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 9, 2002
- Review
- 145 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970720 (1997). 8 ancestors in all, the oldest K890841 (1989). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK022313 Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM -…Power Medical Interventions, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK073148 Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK091215 Intelligent Power Unit, Intelligent Console, Intelligent Delivery…Power Medical Interventions, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK081826 Intelligent Straight and Articular Endoscopic Linear Cutters…Power Medical Interventions, Inc. · 2008 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007 · cites it directly1descendant
- K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc. · 2009 · 2 generations on0descendants
- K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc. · 2008 · cites it directly0descendants
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) | K022313 | Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with… | Power Medical Interventions, Inc. | 2002 | — |
| +1 | K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | Power Medical Interventions, Inc. | 2007 | — |
| +2 | K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System… | Power Medical Interventions, Inc. | 2009 | 1 |
| +1 | K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with… | Power Medical Interventions, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K021701 | Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60Summary page 2…h Titanium Implantable Staples and Reloads, Power Medical Interventions, Inc., New Hope, PA. REF RALC30, RALC45, RALCGO, RALCR30, RALCR45, RALCRGO (K021701). b) ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, VascularTThin. Ethicon Endo-Surgery, Inc., Cin… | 2002 |
| * | K002398 | Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets…Summary page 2…701). b) ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, VascularTThin. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF SCW45 (K002398). 4) Device Description: The devices described here are Right Angle Linear Cutter Digital Loading UnitsTM(DLUs),30 mm,… | 2000 |
What descends from it? (3)
2 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)
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 5 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K073148 (Power Medical Interventions, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K021701.
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 SurgASSISTTM Right Angle Linear Cutter Digital Loading
UnitTM, 30 mm, 45 mm and 60 mm, Vascular with Reloads has
applications for general and endoscopic surgery including multiple
open or minimally invasive general, gynecological, urologic
(including radical prostatectomy), thoracic, and pediatric surgical
procedures for transection, resection, and/or creation of
anastomoses. They can be used with staple line or tissue
buttressing material such as bovine pericardium.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022313: Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V & RALC60V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022313
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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