510(k) · Cleared
ClearedMyEllevate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jul 6, 2023 as substantially equivalent to K091061 (Implicitcare, LLC, 2009) and 2 other predicates after a 132-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Jul 6, 2023
- Review
- 132 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K014153 (2002). 9 ancestors in all, the oldest K930738 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 4 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 3 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 2 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 1 generation backK091061 Implicitguide Surgical Suture SystemImplicitcare, LLC · 2009
- This deviceK230510 MyEllevateCynosure, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −4 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −3 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −2 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −1 | K091061 | Implicitguide Surgical Suture System | Implicitcare, LLC | 2009 | — |
| 0 (this device) | K230510 | MyEllevate | Cynosure, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K091061 | Implicitguide Surgical Suture SystemSummary page 5…uct Code(s) GAT 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed Implicitguide Surgical Suture System (K091061) TEVDEK ® Predicate Devices Polyester Suture (K1001434, K021019) 807.92(a)(4) Device Description… | 2009 |
| * | K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureSummary page 7…Implicitguide Surgical Suture TEVDEK ® II Suture (K230510) System (K001434, K021019) (K091061) Indication for Use The MyEllevate… | 2000 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 5…claimed Implicitguide Surgical Suture System (K091061) TEVDEK ® Predicate Devices Polyester Suture (K1001434, K021019) 807.92(a)(4) Device Description The MyEllevate device consists of a Surgical Suture System… | 2002 |
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
MyEllevate is indicated for use in soft tissue approximation and elevation of sub dermis and underlying muscle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230510: MyEllevate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230510
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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