510(k) · Cleared
Recalled · 2007Nextstitch Cardiovascular Valve Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Surgical Product (Genzyme Biosurgery) · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Nov 13, 2000 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2000
- Review
- 189 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 1
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK001440 Nextstitch Cardiovascular Valve SutureGenzyme Surgical Product (Genzyme Biosurgery) · 2000
- Descendant · cites it directly · 11 of its ownK060165 Axyaflex Polyester SutureAxya Medical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK022410 Saph-Loop Ligating LoopGenzyme Biosurgery · 2002
- Descendant · 3 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK153076 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II…Teleflexmedical, Inc. · 2016
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K060165Axyaflex Polyester SutureAxya Medical, Inc. · 2006 · cites it directly11descendants
- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on9descendants
- K022410Saph-Loop Ligating LoopGenzyme Biosurgery · 2002 · cites it directly5descendants
- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 3 generations on4descendants
- K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc. · 2016 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001440 | Nextstitch Cardiovascular Valve Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 2000 | — |
| +1 | K060165 | Axyaflex Polyester Suture | Axya Medical, Inc. | 2006 | — |
| +2 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +1 | K022410 | Saph-Loop Ligating Loop | Genzyme Biosurgery | 2002 | — |
| +3 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +1 | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX… | Teleflexmedical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Jun 6, 2007 | Not classified | Z-1017-2007 | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060165 (Axya Medical, Inc., 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
https://510kreport.com/device/K001440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001440: Nextstitch Cardiovascular Valve Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001440
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026