510(k) · Cleared
ClearedLariat Loop Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentreheart · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jun 2, 2006 as substantially equivalent to K963329 (ETHICON, Inc., 1996) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931994 (1994). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931994 Resectoscope SheathOlympus Corp. · 1994
- 1 generation backK993695 Liga-Loop Suture ApplicatorHysterx, Inc. · 2000
- This deviceK060721 Lariat Loop ApplicatorSentreheart · 2006
- Descendant · cites it directly · 2 of its ownK090385 Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK142241 LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK153096 LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK073096 Anchorage Closure DeviceEpitek, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K090385Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009 · cites it directly2descendants
- K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014 · 2 generations on1descendant
- K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015 · 3 generations on0descendants
- K073096Anchorage Closure DeviceEpitek, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931994 | Resectoscope Sheath | Olympus Corp. | 1994 | — |
| −1 | K993695 | Liga-Loop Suture Applicator | Hysterx, Inc. | 2000 | — |
| 0 (this device) | K060721 | Lariat Loop Applicator | Sentreheart | 2006 | — |
| +1 | K090385 | Lariat II Suture Delivery Device | Sentreheart, Inc. | 2009 | — |
| +2 | K142241 | LARIAT sulture Delivery Device | Sentreheart, Inc. | 2014 | — |
| +3 | K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | 2015 | — |
| +1 | K073096 | Anchorage Closure Device | Epitek, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K963329 | Ethicon Endosuture SystemSummary page 1…re-tied polyester suture. Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Ethicon Endosuture System (K963329), the Genzyme Saph-Loop Ligating Loop (K022410), and the HysteRx Liga-Loop Suture Applicator (K993695). Test Results: Performan… | 1996 |
| * | K022410 | Saph-Loop Ligating LoopSummary page 1…he subject device is substantially equivalent in intended use and/or method of operation to the Ethicon Endosuture System (K963329), the Genzyme Saph-Loop Ligating Loop (K022410), and the HysteRx Liga-Loop Suture Applicator (K993695). Test Results: Performance Results of in-vitro testing demonstrate that… | 2002 |
| * | K993695 | Liga-Loop Suture ApplicatorSummary page 1…ed use and/or method of operation to the Ethicon Endosuture System (K963329), the Genzyme Saph-Loop Ligating Loop (K022410), and the HysteRx Liga-Loop Suture Applicator (K993695). Test Results: Performance Results of in-vitro testing demonstrate that the LARIAT Loop Applicator is safe and effective for i… | 2000 |
What descends from it? (4)
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 12 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K090385 (Sentreheart, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K963329.
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 LARIAT Loop Applicator facilitates suture placement and knot tying for use in surgical
applications where soft tissue are being approximated and/or ligated with a pre-tied polyester
suture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060721: Lariat Loop Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060721
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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