510(k) · Cleared
Recalled · Class II · 2017Synthetic Absorbable Surgical 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 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Oct 8, 1996 after a 50-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 1996
- Review
- 50 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK963253 Synthetic Absorbable Surgical SutureUnited States Surgical, A Division of Tyco Healthc · 1996
- Descendant · cites it directly · 8 of its ownK970863 Modified Ussc* Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · 2 generations on · 7 of its ownK981935 Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1998 · Recalled
- Descendant · 3 generations on · 3 of its ownK063536 Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group · 2007
- Descendant · 3 generations on · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
- Descendant · 4 generations on · 2 of its ownK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K970863Modified Ussc* Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1997 · cites it directly8descendants
- K981935Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1998 · 2 generations on7descendants
- K063536Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group · 2007 · 3 generations on3descendants
- K202950StitchKit COMBOOrigami Surgical · 2021 · 3 generations on2descendants
- K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963253 | Synthetic Absorbable Surgical Suture | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| +1 | K970863 | Modified Ussc* Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +2 | K981935 | Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1998 | 1 |
| +3 | K063536 | Polysorb* Synthetic Absorbable Suture with Modified Packaging | Tyco Healthcare Group | 2007 | — |
| +3 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| +4 | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 14.8 · 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 |
|---|---|---|---|
| * | — | USSC POLYSORB suture Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970863 | Modified Ussc* Polysorb Suture | 1997 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2017 | Class II | Z-2541-2017 | Process control | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K970863 (United States Surgical, A Division of Tyco Healthc, 1997) has gone furthest, with 8 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?
USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.
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/K963253 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963253: 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/K963253
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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