510(k) · Cleared
ClearedValutrus Reusable Circular Stapler and Disposable Reloads
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 Aug 3, 2011 as substantially equivalent to K983536 (Ethicon Endo-Surgery, Inc., 1998) after a 97-day review. Its family tree reaches back 2 generations to 1994. 2 of the 3 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 3, 2011
- Review
- 97 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940967 (1994). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 1 generation backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- This deviceK111195 Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −1 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| 0 (this device) | K111195 | Valutrus Reusable Circular Stapler and Disposable Reloads | Ethicon Endo-Surgery, Inc. | 2011 | — |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K983536 | Proximate Curved and Straight Intraluminal StaplersSummary page 1…Classification Name: Staple, Implantable Predicate Device: PROXIMATE®ILS Curved and Straight Intraluminal Staplers (cleared under K983536 cleared on December 18, 1998) Device Description: The ValuTruSTM Reusable Circular Stapler and Disposable Reloads consists of a… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 12.6 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- 8 other devices also cite its predicate K983536.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ValuTrusTM Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111195: Valutrus Reusable Circular Stapler and Disposable Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111195
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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