510(k) · Cleared
ClearedContour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable
Cleared on Jun 1, 2009 as substantially equivalent to K062869 (Ethicon Endo-Surgery, LLC, 2007) after a 27-day review. Its family tree reaches back 3 generations to 1984. 60 later devices descend from it.
- Decided
- Jun 1, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K843034 (1984). 5 ancestors in all. 60 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK843034 Disposable Linear CutterETHICON, Inc. · 1984
- 2 generations backK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
- 1 generation backK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
- This deviceK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
- Descendant · cites it directly · 45 of its ownK102291 Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010
- Descendant · 2 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- Descendant · cites it directly · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- Descendant · cites it directly · 9 of its ownK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
- Descendant · 2 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K102291Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010 · cites it directly45descendants
- K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 2 generations on44descendants
- K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · cites it directly14descendants
- K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · cites it directly9descendants
- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K843034 | Disposable Linear Cutter | ETHICON, Inc. | 1984 | — |
| −2 | K040038 | Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models… | Ethicon Endo-Surgery, Inc. | 2004 | — |
| −1 | K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40G | Ethicon Endo-Surgery, LLC | 2007 | — |
| 0 (this device) | K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G | Ethicon Endo-Surgery, Inc. | 2009 | — |
| +1 | K102291 | Covidien Endo Gia Radial Reload with Tri-Staple Technology | Covidien | 2010 | — |
| +2 | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 73 |
| +1 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
| +1 | K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
| +2 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GSummary page 1…eloads Common or Usual Name: Cutter/Stapler and Reloads Classification Name: Staple, Implantable Predicate Device K062869 - CONTOURT m Curved Cutter Stapler and Reloads Device Description: The CONTOURTm Curved Cutter Stapler is a multifire, si… | 2007 |
What descends from it? (60)
See all 605 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102291 | Covidien Endo Gia Radial Reload with Tri-Staple Technology | 2010 | 45 |
| K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear… | 2013 | 14 |
| K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | 2010 | 9 |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green… | 2020 | 0 |
| K152618 | PANTHER Cutter Stapler | 2015 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102291 (Covidien, 2010) has gone furthest, with 45 descendants of its own.
- 3 other devices also cite its predicate K062869.
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 CONTOURTM Curved Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091322: Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091322
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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