510(k) · Cleared
ClearedWG-Surgical Sutures with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foosin Medical Supplies, Inc. · GAP Suture, Nonabsorbable, Silk
Cleared on Jun 9, 2008 as substantially equivalent to K041514 (Sutures India Private Limited, 2005) and 3 other predicates after a 91-day review. Its family tree reaches back 3 generations to 1993. 9 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K930586 (1993). 15 ancestors in all, the oldest K902873 (1990). 9 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- 2 generations backK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998 · Recalled
- 1 generation backK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- This deviceK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK232355 Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · cites it directly4descendants
- K173747RexleneSm Eng Co., Ltd. · 2018 · cites it directly1descendant
- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 2 generations on1descendant
- K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 2 generations on0descendants
- K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| −2 | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | 9 |
| −1 | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| 0 (this device) | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +1 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +1 | K173747 | Rexlene | Sm Eng Co., Ltd. | 2018 | — |
| +2 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
| +2 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide… | Safepath Medical, Inc. | 2024 | — |
| +2 | K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 GAP? 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 GAP device
- #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K041514 | Truesilk Non-Absorbable Silk Surgical SutureSummary page 2…-5 10(k) Summary Report No.: A20071012 and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. 1.2Predicate Device K-number: K041514 1.3 Device Description The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made… | 2005 |
| * | K070243 | Sutralene Polypropylene SuturesSummary page 2…general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. 2.2Predicate Device K-number: K070243 2.3Device Description The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical… | 2007 |
| * | K060165 | Axyaflex Polyester SutureSummary page 3…use in general soft tissue a ximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. 3.2Predicate Device K-number: K060165 3.3Device Description The applicant devices of nonabsorbable polyester suture with needle consist of a polyester surgical… | 2006 |
| * | K060471 | FSSB Nylon Surgical SuturesSummary page 3…needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. 4.2Predicate Device K-number: K0060471 4.3Device Description Shanghai Mid-Link Business Consulting Co., Ltd Prema… | 2006 |
What descends from it? (9)
5 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K161633 (Sm Eng Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K041514.
How does its category compare?
All GAP devicesGAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GAP
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAP
193in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAP
478in 2025
MAUDE reports naming product code GAP, 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 | 1 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 21 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 2 | — | 0 | 54 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 1 | — | 1 | 340 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 0 | — | 0 | 426 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 419 |
| 2023 | 1 | — | 1 | 404 |
| 2024 | 3 | 193 | 0 | 455 |
| 2025 | 0 | — | 0 | 478 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polypropylene Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polyester Suture with Needle is indicated for use in general soft…
Read the full statement (93 words)
Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polypropylene Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080684: WG-Surgical Sutures with Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080684
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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