510(k) · Cleared
ClearedImplicitguide Surgical Suture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implicitcare, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Nov 13, 2009 as substantially equivalent to K001434 (Genzyme Surgical Product (Genzyme Biosurgery), 2000) and 2 other predicates after a 213-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Nov 13, 2009
- Review
- 213 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K014153 (2002). 8 ancestors in all, the oldest K930738 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 3 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 2 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 1 generation backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- This deviceK091061 Implicitguide Surgical Suture SystemImplicitcare, LLC · 2009
- Descendant · cites it directly · 0 of its ownK230510 MyEllevateCynosure, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K230510MyEllevateCynosure, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −3 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −2 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −1 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| 0 (this device) | K091061 | Implicitguide Surgical Suture System | Implicitcare, LLC | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureSummary page 1…device is substantially equivalent, in whole or in part, to the following commercially available predicate device: * TEVDEK® IIPolyester Sututre -K001434, K021019; Genzyme Corp. * Featherlift Extended Length Aptos Threads (Contour Threads) - K04 1593;… | 2000 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 1…substantially equivalent, in whole or in part, to the following commercially available predicate device: * TEVDEK® IIPolyester Sututre -K001434, K021019; Genzyme Corp. * Featherlift Extended Length Aptos Threads (Contour Threads) - K04 1593; Surgic… | 2002 |
| * | K041593 | Featherlift Extended Length Aptos ThreadSummary page 1…te device: * TEVDEK® IIPolyester Sututre -K001434, K021019; Genzyme Corp. * Featherlift Extended Length Aptos Threads (Contour Threads) - K04 1593; Surgical Specialties Corporation 5.4 Device Description The ImplicitCare ImplicitguideTM Surgical… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230510 | MyEllevate | 2023 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K230510 (Cynosure, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K001434.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Implicitguide TM Surgical Suture System is indicated for use in soft tissue approximation and elevation of subdermis and underlying muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091061: Implicitguide Surgical Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091061
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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