510(k) · Cleared
ClearedDextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dextera Surgical, Inc. · GDW Staple, Implantable
Cleared on Aug 28, 2017 as substantially equivalent to K070887 (Ethicon Endo-Surgery, LLC, 2007) after a 90-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Aug 28, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070887 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070887 Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear…Ethicon Endo-Surgery, LLC · 2007 · Recalled
- This deviceK171561 Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved…Dextera Surgical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters… | Ethicon Endo-Surgery, LLC | 2007 | 4 |
| 0 (this device) | K171561 | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue… | Dextera Surgical, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 4…er: 21 CFR §878.4750 Product Code: GDW E. Marketed Predicate Devices Ethicon ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and (Reloads) (K070887) Reference Devices MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload… | 2007 |
| † | K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter… | 2016 |
| † | K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | 2016 |
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?
- Its one ancestor has a recall.
- 10 other devices also cite its predicate K070887.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171561 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171561: Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171561
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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