510(k) · Cleared
Recalled · 2010Auto Suture* Modified Endoscopic Fascia Stapler** Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · OCW Endoscopic Tissue Approximation Device
Cleared on Nov 27, 1996 as substantially equivalent to K944415 (Origin Medsystems, Inc., 1994) after a 51-day review. Its family tree reaches back 1 generation to 1994. 23 later devices descend from it. It has been recalled once.
- Decided
- Nov 27, 1996
- Review
- 51 days
- Class
- Class II
- Product code
- OCW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944415 (1994). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- This deviceK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996
- Descendant · cites it directly · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
- Descendant · cites it directly · 7 of its ownK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK023372 Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- Descendant · 2 generations on · 4 of its ownK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · cites it directly12descendants
- K013749Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002 · cites it directly7descendants
- K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 2002 · 2 generations on6descendants
- K061276G-Prox Endoscopic GrasperUsgi Medical · 2006 · 2 generations on5descendants
- K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944415 | Origin Tacker System | Origin Medsystems, Inc. | 1994 | — |
| 0 (this device) | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| +1 | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Covidien | 2009 | 2 |
| +1 | K013749 | Endoanchor and Openanchor | Ethicon Endo-Surgery, Inc. | 2002 | — |
| +2 | K023372 | Non-Bioabsorbable Staple | Onux Medical, Inc. | 2002 | — |
| +2 | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| +2 | K123109 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.1 · 5 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 |
|---|---|---|---|
| * | K944415 | Origin Tacker SystemSummary page 1…6 CLASSIFICATION NAME: Implantable Staple COMMON NAME: Surgical Staple PROPRIETARY NAME: Trademark name not yet determined. PREDICATE DEVICE: Origin® Tacker™ System (K944415) DEVICE DESCRIPTION: The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is an endoscopic stapling device. The device i… | 1994 |
What descends from it? (23)
See all 233 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2010 | Not classified | Z-1157-2010 | Process control | Fixation device may fail to fire and staple. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.
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/K963999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963999: Auto Suture* Modified Endoscopic Fascia Stapler** Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963999
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