510(k) · Cleared
ClearedLiga-Loop Suture Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hysterx, Inc. · GAL Suture, Absorbable, Natural
Cleared on Apr 13, 2000 as substantially equivalent to K950126 (Advanced Surgical, Inc., 1995) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Apr 13, 2000
- Review
- 163 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931994 (1994). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK931994 Resectoscope SheathOlympus Corp. · 1994
- This deviceK993695 Liga-Loop Suture ApplicatorHysterx, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK060721 Lariat Loop ApplicatorSentreheart · 2006
- Descendant · 2 generations on · 2 of its ownK090385 Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK142241 LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK153096 LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
- Descendant · 2 generations on · 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 · 2 generations on2descendants
- K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014 · 3 generations on1descendant
- K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015 · 4 generations on0descendants
- K073096Anchorage Closure DeviceEpitek, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931994 | Resectoscope Sheath | Olympus Corp. | 1994 | — |
| 0 (this device) | K993695 | Liga-Loop Suture Applicator | Hysterx, Inc. | 2000 | — |
| +1 | K060721 | Lariat Loop Applicator | Sentreheart | 2006 | — |
| +2 | K090385 | Lariat II Suture Delivery Device | Sentreheart, Inc. | 2009 | — |
| +3 | K142241 | LARIAT sulture Delivery Device | Sentreheart, Inc. | 2014 | — |
| +4 | K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | 2015 | — |
| +2 | K073096 | Anchorage Closure Device | Epitek, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 GAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K950126 | Endoscopic Ligation Device, Ligator Handle, Ligator CartridgeSummary page 1…or legally marketed device or devices to which substantial equivalence is being claimed: a. Company: Advanced Surgical, Inc. Device: Endoscopic Ligation Device 510(k): K950126 Date Cleared: April 13, 1995 b. Company: Olympus Corporation Device: Resectoscope Sheath 510¢k): K931994/A LIGA-LOQP Suture Appli… | 1995 |
| * | K931994 | Resectoscope SheathSummary page 1…vanced Surgical, Inc. Device: Endoscopic Ligation Device 510(k): K950126 Date Cleared: April 13, 1995 b. Company: Olympus Corporation Device: Resectoscope Sheath 510¢k): K931994/A LIGA-LOQP Suture Applicator K993695 Summary of Safety and Effectiveness March 30, 2000 lof4 Page 3/5 Date Cle… | 1994 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060721 | Lariat Loop Applicator | 2006 | 4 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K060721 (Sentreheart, 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GAL
Too few GAL 510(k)s in any year since 2007 to give a median.
Recalls per year · GAL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAL
117in 2025
MAUDE reports naming product code GAL, 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 | 13 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 57 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 157 |
| 2015 | 1 | — | 0 | 137 |
| 2016 | 0 | — | 0 | 87 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 0 | — | 0 | 246 |
| 2019 | 0 | — | 1 | 229 |
| 2020 | 0 | — | 0 | 109 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 130 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 117 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993695: Liga-Loop Suture Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993695
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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