510(k) · Cleared
ClearedEndoanchor and Openanchor
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 Feb 11, 2002 as substantially equivalent to K913469 (ETHICON, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944415 (1994). 3 ancestors in all, the oldest K913469 (1991). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- 1 generation backK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- This deviceK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK023372 Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- Descendant · 2 generations on · 1 of its ownK100251 G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010
- Descendant · 2 generations on · 1 of its ownK093018 G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009
- Descendant · 3 generations on · 0 of its ownK103688 G-Prox EZ Endoscopic GrasperUsgi Medical · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 2002 · cites it directly6descendants
- K061276G-Prox Endoscopic GrasperUsgi Medical · 2006 · cites it directly5descendants
- K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010 · 2 generations on1descendant
- K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009 · 2 generations on1descendant
- K103688G-Prox EZ Endoscopic GrasperUsgi Medical · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944415 | Origin Tacker System | Origin Medsystems, Inc. | 1994 | — |
| −1 | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| 0 (this device) | K013749 | Endoanchor and Openanchor | Ethicon Endo-Surgery, Inc. | 2002 | — |
| +1 | K023372 | Non-Bioabsorbable Staple | Onux Medical, Inc. | 2002 | — |
| +1 | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| +2 | K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333 | Usgi Medical | 2010 | — |
| +2 | K093018 | G-Prox Endoscopic Grasper, Model 205333 | Usgi Medical | 2009 | — |
| +3 | K103688 | G-Prox EZ Endoscopic Grasper | Usgi Medical | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K913469 | Endopath Disposable Endoscopic Multifeed StaplerSummary page 1…HOR and OpenANCHOR Fixation Devices Classification Name: Stapler, General & Plastic Surgery Predicate Devices: e Ethicon Endo-Surgery, Inc. ENDOPATH EMS cleared under K913469 on September 30 1991. o United States Surgical Corp. AutoSuture™ ProTack™ cleared under K963999 on November 27, 1996. Device De… | 1991 |
| * | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** DeviceSummary page 1…dicate Devices: e Ethicon Endo-Surgery, Inc. ENDOPATH EMS cleared under K913469 on September 30 1991. o United States Surgical Corp. AutoSuture™ ProTack™ cleared under K963999 on November 27, 1996. Device Description: The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instru… | 1996 |
What descends from it? (7)
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)
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 8 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K023372 (Onux Medical, Inc., 2002) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K913469.
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 EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
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/K013749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013749: Endoanchor and Openanchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013749
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026