510(k) · Cleared
ClearedLifestitch Suturing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Feb 27, 2002 as substantially equivalent to K972911 (United States Surgical, A Division of Tyco Healthc, 1998) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 27, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K972911 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972911 Auto Suture*Endostitch* II** Suture ApplierUnited States Surgical, A Division of Tyco Healthc · 1998
- This deviceK013990 Lifestitch Suturing DeviceEdwards Lifesciences, LLC · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972911 | Auto Suture*Endostitch* II** Suture Applier | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| 0 (this device) | K013990 | Lifestitch Suturing Device | Edwards Lifesciences, LLC | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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 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? (3)
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 |
|---|---|---|---|
| * | K972911 | Auto Suture*Endostitch* II** Suture ApplierSummary page 1…ciate February 14, 2000 LifeStitch Suturing Device Nonabsorbable poly(ethylene terephthalate) surgical suture e Auto Suture™ ENDO STITCH™ Disposable Suturing Device (K972911) e Sew-Right® SRe5™ Precision Remote Suturing Device (K011016) e Novafil™ suture material (K990952) The Edwards LifeStitch Sut… | 1998 |
| * | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories ProductSummary page 1…able poly(ethylene terephthalate) surgical suture e Auto Suture™ ENDO STITCH™ Disposable Suturing Device (K972911) e Sew-Right® SRe5™ Precision Remote Suturing Device (K011016) e Novafil™ suture material (K990952) The Edwards LifeStitch Suturing Device is a sterile, single use only device that uses asp… | 2001 |
| * | K990952 | Novafil** and Vascufil** Sterile Synthetic Non-Absorbable SuturesSummary page 1…ical suture e Auto Suture™ ENDO STITCH™ Disposable Suturing Device (K972911) e Sew-Right® SRe5™ Precision Remote Suturing Device (K011016) e Novafil™ suture material (K990952) The Edwards LifeStitch Suturing Device is a sterile, single use only device that uses aspiration and mechanically activated sur… | 1999 |
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?
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K972911.
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 | — |
What is it indicated for?
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.
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/K013990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013990: Lifestitch Suturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013990
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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