510(k) · Cleared
ClearedSutralene Polypropylene Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionary Medical Supplies, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Apr 17, 2007 after an 82-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 10 later devices descend from it.
- Decided
- Apr 17, 2007
- Review
- 82 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 1
10 later devices descend from it, 1 citing it directly.
- This deviceK070243 Sutralene Polypropylene SuturesVisionary Medical Supplies, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · cites it directly9descendants
- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 2 generations on4descendants
- K173747RexleneSm Eng Co., Ltd. · 2018 · 2 generations on1descendant
- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 3 generations on1descendant
- K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070243 | Sutralene Polypropylene Sutures | Visionary Medical Supplies, Inc. | 2007 | — |
| +1 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +2 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +2 | K173747 | Rexlene | Sm Eng Co., Ltd. | 2018 | — |
| +3 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
| +3 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide… | Safepath Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P16374 | Ethicon PROLENE Nonabsorbable polypropylene sutures Number could not be read Summary page 1…cal Supplies are equivalent to Ethicon PROLENE* nonabsorbable polypropylene sutures. The Ethicon PROLENE Nonabsorable polypropylene sutures were approved by PMA N16374. Subsequent to the PMA, polypropylene sutures were down classified and require clearance to market by 510(k), File:Visi… |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080684 | WG-Surgical Sutures with Needle | 2008 | 9 |
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?
- Of its descendants, K080684 (Foosin Medical Supplies, Inc., 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070243: Sutralene Polypropylene Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070243
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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