510(k) · Cleared
Recalled · 2009Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60
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 Jun 21, 2002 as substantially equivalent to K012809 (Power Medical Interventions, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 21, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970720 (1997). 6 ancestors in all, the oldest K890841 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 1 generation backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- This deviceK021701 Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models…Power Medical Interventions, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK022313 Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM -…Power Medical Interventions, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK073148 Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK091215 Intelligent Power Unit, Intelligent Console, Intelligent Delivery…Power Medical Interventions, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK081826 Intelligent Straight and Articular Endoscopic Linear Cutters…Power Medical Interventions, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK052910 Power Right Angle Linear Cutter Digital Loading Unit with ReloadsPower Medical Interventions, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K022313Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads…Power Medical Interventions, Inc. · 2002 · cites it directly3descendants
- K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007 · 2 generations on1descendant
- K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc. · 2009 · 3 generations on0descendants
- K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc. · 2008 · 2 generations on0descendants
- K052910Power Right Angle Linear Cutter Digital Loading Unit with ReloadsPower Medical Interventions, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −1 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K021701 | Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45… | Power Medical Interventions, Inc. | 2002 | — |
| +1 | K022313 | Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with… | Power Medical Interventions, Inc. | 2002 | — |
| +2 | K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | Power Medical Interventions, Inc. | 2007 | — |
| +3 | K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System… | Power Medical Interventions, Inc. | 2009 | 1 |
| +2 | K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with… | Power Medical Interventions, Inc. | 2008 | 1 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012809 | Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Summary page 1…ght Angle Linear Cutter Digital Loading UnitTMwith Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF RALC45. (K012809). Power Medical Interventions, Inc. SurgASSISTTMRight Angle Linear Cutter DLUs with Reloads, 30mm.45mm,60mm Speci… | 2001 |
| * | K980815 | Endopath EZ45 Endoscopic Linear CutterSummary page 2…dification PreMarket Notification, May 20, 2002 b) EZ45 Endoscopic Linear Cutter/Stapler Reloads. Ethicon Endo- Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815). 4) Device Description: The devices described here are reloadable Right Angle Linear Cutter DLUs for single patient use.… | 1998 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2009 | Not classified | Z-0394-2010 | 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 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K022313 (Power Medical Interventions, Inc., 2002) has gone furthest, with 3 descendants of its own.
- 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 SurgASSISTTMSystem Right Angle Linear Cutter Digital
Loading UnitTM (DLU) with Reloads has applications in
gastrointestinal, gynecological, general abdominal and thoracic
surgical procedures for resection, transection, and creation of
anastomoses.
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/K021701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021701: Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021701
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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