510(k) · Cleared
ClearedAuto Suture Modified Surgitie Endo. Ligating Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jan 17, 1991 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 17, 1991
- Review
- 48 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK905379 Auto Suture Modified Surgitie Endo. Ligating LoopUnited States Surgical, A Division of Tyco Healthc · 1991
- 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905379 | Auto Suture Modified Surgitie Endo. Ligating Loop | United States Surgical, A Division of Tyco Healthc | 1991 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090385 | Lariat II Suture Delivery Device | 2009 | 2 |
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?
- Of its descendants, K090385 (Sentreheart, Inc., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K905379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905379: Auto Suture Modified Surgitie Endo. Ligating Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905379
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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