510(k) · Cleared
ClearedAbsorbable Surgical Gut Suture*
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 · GAL Suture, Absorbable, Natural
Cleared on Aug 22, 1989 after a 260-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.
- Decided
- Aug 22, 1989
- Review
- 260 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly.
- This deviceK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- Descendant · cites it directly · 43 of its ownK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
- Descendant · 2 generations on · 29 of its ownK040477 MonodermSurgical Specialties Corp · 2004
- Descendant · 3 generations on · 28 of its ownK052437 Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005
- Descendant · 4 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- Descendant · 5 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002 · cites it directly43descendants
- K040477MonodermSurgical Specialties Corp · 2004 · 2 generations on29descendants
- K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005 · 3 generations on28descendants
- K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 4 generations on26descendants
- K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| +1 | K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | 2002 | — |
| +2 | K040477 | Monoderm | Surgical Specialties Corp | 2004 | — |
| +3 | K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable Suture | Surgical Specialties Corp | 2005 | — |
| +4 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| +5 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 452 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?
- Of its descendants, K013671 (United States Surgical, A Division of Tyco Healthc, 2002) has gone furthest, with 43 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 | — |
https://510kreport.com/device/K885018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K885018: Absorbable Surgical Gut Suture*.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885018
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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