510(k) · Cleared
Recalled · 2010Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Aug 2, 1996 after a 37-day review. The FDA summary names its predicate without a number. 76 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 1996
- Review
- 37 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 2
- Predicates
- 0
76 later devices descend from it, 4 citing it directly.
- This deviceK962480 Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable…ETHICON, Inc. · 1996
- Descendant · cites it directly · 68 of its ownK024117 Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- Descendant · 3 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- Descendant · 3 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- Descendant · 3 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · cites it directly68descendants
- K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · 2 generations on64descendants
- K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 3 generations on31descendants
- K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 3 generations on30descendants
- K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962480 | Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture… | ETHICON, Inc. | 1996 | — |
| +1 | K024117 | Insorb Absorbable Staples, Model SP-B20 | Incisive Surgical, Inc. | 2003 | 1 |
| +2 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| +3 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| +3 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| +3 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 14.8 · 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? (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 |
|---|---|---|---|
| * | — | Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable suture, undyed Named without a submission number |
What descends from it? (76)
See all 764 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 |
|---|---|---|---|---|
| Apr 20, 2010 | Not classified | Z-1608-2010 | Other | Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe. |
| Aug 11, 2008 | Not classified | Z-0021-2009 | Packaging | Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K024117 (Incisive Surgical, Inc., 2003) has gone furthest, with 68 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 | — |
What is it indicated for?
6-0 undyed Coated VICRYL RAPIDE suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or 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/K962480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962480: Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962480
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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