510(k) · Cleared
ClearedDextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardica, Inc. · GDW Staple, Implantable
Cleared on Jul 20, 2016 as substantially equivalent to K132581 (Cardica, Inc., 2014) and 3 other predicates after an 89-day review. Its family tree reaches back 13 generations to 1985.
- Decided
- Jul 20, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K842066 (1985). 62 ancestors in all, the oldest K821994 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations between
- 3 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 2 generations backK132581 Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple…Cardica, Inc. · 2014 · Recalled
- 1 generation backK140170 Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc. · 2014 · Recalled
- This deviceK161137 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue…Cardica, Inc. · 2016
Show all 13 generations
- Root · 13 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 12 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 10 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 9 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 8 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 7 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 6 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 5 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 4 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 3 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 2 generations backK132581 Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple…Cardica, Inc. · 2014 · Recalled
- 1 generation backK140170 Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc. · 2014 · Recalled
- This deviceK161137 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue…Cardica, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −12 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −10 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −9 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −8 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −7 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −6 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −5 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −4 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| −3 | 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 |
| −2 | K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue… | Cardica, Inc. | 2014 | 1 |
| −1 | K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge | Cardica, Inc. | 2014 | 2 |
| 0 (this device) | K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip… | Cardica, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Summary page 4…croCutter XCHANGE® 30 Blue Curved Tip Cartridge MicroCutter XCHANGE® 30 White Cartridge MicroCutter XCHANGE® 30 White Curved Tip Cartridge (K132581, K140118, K140170 and K151081) F. Device Description The size of the Dextera MicroCutter 5/80™ Blue Reload and… | 2014 |
| * | K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeSummary page 4…XCHANGE® 30 Blue Curved Tip Cartridge MicroCutter XCHANGE® 30 White Cartridge MicroCutter XCHANGE® 30 White Curved Tip Cartridge (K132581, K140118, K140170 and K151081) F. Device Description The size of the Dextera MicroCutter 5/80™ Blue Reload and Dextera M… | 2014 |
| * | K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeSummary page 4…30 Blue Curved Tip Cartridge MicroCutter XCHANGE® 30 White Cartridge MicroCutter XCHANGE® 30 White Curved Tip Cartridge (K132581, K140118, K140170 and K151081) F. Device Description The size of the Dextera MicroCutter 5/80™ Blue Reload and Dextera MicroCutte… | 2014 |
| * | K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…Summary page 4…ved Tip Cartridge MicroCutter XCHANGE® 30 White Cartridge MicroCutter XCHANGE® 30 White Curved Tip Cartridge (K132581, K140118, K140170 and K151081) F. Device Description The size of the Dextera MicroCutter 5/80™ Blue Reload and Dextera MicroCutter… | 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?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 62 ancestors have a recall of any class.
- 2 other devices also cite its predicate K132581.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161137: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161137
Report an extraction error
Are you the manufacturer?
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