510(k) · Cleared
ClearedAesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 29, 2001 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 29, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK011375 Aesculap, Inc., Monosyn Synthetic Absorbable Surgical SutureAesculap, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK031286 Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK233265 Monotime and Optime RPeters Surgical · 2024
- Descendant · cites it directly · 0 of its ownK171001 Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK073493 Hepatostat SetVygon Corp. · 2008
Most influential descendants
Showing 5 of 5 · See all- K031286Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · cites it directly3descendants
- K061796Hepatostat Set, Model 760XVygon Corp. · 2006 · cites it directly1descendant
- K233265Monotime and Optime RPeters Surgical · 2024 · 2 generations on0descendants
- K171001Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2017 · cites it directly0descendants
- K073493Hepatostat SetVygon Corp. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011375 | Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2001 | — |
| +1 | K031286 | Safil and Safil Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2003 | 1 |
| +1 | K061796 | Hepatostat Set, Model 760X | Vygon Corp. | 2006 | — |
| +2 | K233265 | Monotime and Optime R | Peters Surgical | 2024 | — |
| +1 | K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2017 | — |
| +2 | K073493 | Hepatostat Set | Vygon Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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? (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?
- Of its descendants, K031286 (Aesculap, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
https://510kreport.com/device/K011375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011375: Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011375
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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