510(k) · Cleared
ClearedPolysorb* Synthetic Absorbable Suture with Modified Packaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Group · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jan 29, 2007 as substantially equivalent to K981935 (United States Surgical, A Division of Tyco Healthc, 1998) after a 68-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Jan 29, 2007
- Review
- 68 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961997 (1996). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961997 Ussc Braided Synthetic Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1996
- 2 generations backK970863 Modified Ussc* Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1997
- 1 generation backK981935 Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1998 · Recalled
- This deviceK063536 Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group · 2007
- Descendant · cites it directly · 2 of its ownK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK200392 RexsinSm Eng Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK173779 Rexmono, PdrexSm Eng Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961997 | Ussc Braided Synthetic Absorbable Suture | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −2 | K970863 | Modified Ussc* Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K981935 | Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1998 | 1 |
| 0 (this device) | K063536 | Polysorb* Synthetic Absorbable Suture with Modified Packaging | Tyco Healthcare Group | 2007 | — |
| +1 | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +2 | K200392 | Rexsin | Sm Eng Co., Ltd. | 2020 | — |
| +2 | K173779 | Rexmono, Pdrex | Sm Eng Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K981935 | Polysorb SutureSummary page 1…: The trade name for the packaging is yet to be determined.) Predicate Device(s): K981935: Modified Polysorb* Suture (manufactured by U.S. Surgical, a division of Ty… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073614 | WG-Surgical Sutures with Needle | 2008 | 2 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K073614 (Foosin Medical Supplies, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K981935.
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. 2007, this device’s year, is highlighted.
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?
Polysorb* Synthetic Absorbable Suture with Modified Packaging is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063536
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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