510(k) · Cleared
ClearedSaph-Loop Ligating Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Biosurgery · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Aug 20, 2002 as substantially equivalent to K001440 (Genzyme Surgical Product (Genzyme Biosurgery), 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Aug 20, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001440 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001440 Nextstitch Cardiovascular Valve SutureGenzyme Surgical Product (Genzyme Biosurgery) · 2000 · Recalled
- This deviceK022410 Saph-Loop Ligating LoopGenzyme Biosurgery · 2002
- Descendant · cites it directly · 4 of its ownK060721 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 5 of 5 · See all- K060721Lariat Loop ApplicatorSentreheart · 2006 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K001440 | Nextstitch Cardiovascular Valve Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 2000 | 1 |
| 0 (this device) | K022410 | Saph-Loop Ligating Loop | Genzyme Biosurgery | 2002 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K001440 | Nextstitch Cardiovascular Valve Suture | 2000 |
What descends from it? (5)
3 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?
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 Saph-Loopm Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022410: Saph-Loop 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/K022410
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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