510(k) · Cleared
Recalled · Class II · 2020Vilet Vilet Quick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 23, 2012 as substantially equivalent to K022269 (ETHICON, Inc., 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it. It has been recalled 41 times.
- Decided
- May 23, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 41
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022269 (2002). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022269 Coated Vicryl* (Polyglactin 910) SutureETHICON, Inc. · 2002 · Recalled
- This deviceK120556 Vilet Vilet QuickRiverpoint Medical · 2012
- Descendant · cites it directly · 0 of its ownK263073 Fast Absorbing PGLARiverpoint Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK123940 Demequicktm (Rapid Absorbable) Synthetic Surgical SutureDemetech Corp. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022269 | Coated Vicryl* (Polyglactin 910) Suture | ETHICON, Inc. | 2002 | 3 |
| 0 (this device) | K120556 | Vilet Vilet Quick | Riverpoint Medical | 2012 | — |
| +1 | K263073 | Fast Absorbing PGLA | Riverpoint Medical, LLC | 2026 | — |
| +1 | K123940 | Demequicktm (Rapid Absorbable) Synthetic Surgical Suture | Demetech Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2026 | 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 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 14.7 · 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? (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 |
|---|---|---|---|
| * | K022269 | Coated Vicryl* (Polyglactin 910) SutureSummary page 2…K120556 Response 05 .2012 MEDICAL Predicate Devices (applicable 510(k) number listed): 1. Ethicon' VicrylO K022269 2. Eth iconO Vicryl Rapide*: K(033 746 Special Controls FDA Guidance 'Class 11Special C… | 2002 |
| * | K033746 | Modified Coated Vicryl* Rapide (Polyglactin 910) Suture | 2003 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2020 | Class II | Z-0949-2021 | Process control | Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence. |
| Aug 3, 2020 | Class II | Z-0010-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0011-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0012-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0013-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0015-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0016-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0018-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0019-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0020-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0025-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0041-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0045-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0014-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0017-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0021-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0022-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0024-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0032-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0034-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0036-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0038-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0043-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0044-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0047-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0026-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0027-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0028-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0029-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0030-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0031-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0035-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0037-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0039-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0040-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0023-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0033-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0042-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0046-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0048-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Aug 3, 2020 | Class II | Z-0049-2021 | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
The 5 latest of 41 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2012, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2007high 10 (2014) · low 1 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
2007high 209 (2015) · low 10 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
2007high 44 (2020) · low 0 (2012)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
2007high 8,970 (2025) · low 194 (2008)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 | — |
What is it indicated for?
PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
PGLA suture is provided sterile as a single use device.
Fast absorbing PGLA surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
PGLA Quick suture is provided sterile as a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120556: Vilet Vilet Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120556
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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