510(k) · Cleared
ClearedSurgisis Staple Line Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Cleared on Aug 23, 2002 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 3 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1992. 6 later devices descend from it.
- Decided
- Aug 23, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- OXE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K921895 (1992). 11 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK022044 Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK170945 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
- Descendant · cites it directly · 1 of its ownK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK201000 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005 · cites it directly3descendants
- K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007 · 2 generations on2descendants
- K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017 · 3 generations on1descendant
- K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · cites it directly1descendant
- K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K022044 | Surgisis Staple Line Reinforcement | Cook Biotech, Inc. | 2002 | — |
| +1 | K051048 | Surgisis Staple Line Reinforcement II | Cook Biotech, Inc. | 2005 | — |
| +2 | K070405 | Modification to Surgisis SLR Staple Line Reinforcement | Cook Biotech, Inc. | 2007 | — |
| +3 | K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017 | — |
| +1 | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | 1 |
| +4 | K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 OXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 1…d is intended for one-time use. PREDICATE DEVICES: . The Surgisis Staple Line Reinforcement is similar to predicate devices, including the Surgisis® Soft Tissue Graft (K980431) and Surgisis® Peripheral Vascular Patch (K001785) manufactured by Cook Biotech Incorporated, the Peri-Strips® Staple Line Reinfo… | 1998 |
| * | K001785 | Surgisis Peripheral Vascular PatchSummary page 1…: . The Surgisis Staple Line Reinforcement is similar to predicate devices, including the Surgisis® Soft Tissue Graft (K980431) and Surgisis® Peripheral Vascular Patch (K001785) manufactured by Cook Biotech Incorporated, the Peri-Strips® Staple Line Reinforcement-Strip (K983 162) manufactured by Biovascul… | 2000 |
| * | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Summary page 1…oft Tissue Graft (K980431) and Surgisis® Peripheral Vascular Patch (K001785) manufactured by Cook Biotech Incorporated, the Peri-Strips® Staple Line Reinforcement-Strip (K983 162) manufactured by Biovascular Incorporated, and the Seamguard® Staple Line Reinforcement Material (K010936) manufactured by W.L. G… | 1998 |
| * | K010936 | Modification to Seamguard Staple Line Reinforcement MaterialSummary page 1…ncorporated, the Peri-Strips® Staple Line Reinforcement-Strip (K983 162) manufactured by Biovascular Incorporated, and the Seamguard® Staple Line Reinforcement Material (K010936) manufactured by W.L. Gore & Associates. K022 9uY Page Zof 2 DEVICE DESCRIPTION: The Surgisis Staple Line Reinf… | 2001 |
What descends from it? (6)
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 10 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K051048 (Cook Biotech, Inc., 2005) has gone furthest, with 3 descendants of its own.
- 28 other devices also cite its predicate K980431.
How does its category compare?
All OXE devicesOXE Mesh, Surgical, Collagen, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXE
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OXE
Too few OXE 510(k)s in any year since 2007 to give a median.
Recalls per year · OXE
No recall names OXE since 2007.
Adverse event reports per year · OXE
No MAUDE report names OXE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Surgisis Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be…
Read the full statement (148 words)
The Surgisis Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis® Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.
The device is supplied sterile and is intended for one-time use.
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/K022044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022044: Surgisis Staple Line Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022044
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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