510(k) · Cleared
ClearedPronova Nonabsorbable Suture, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Jul 10, 2000 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.
- Decided
- Jul 10, 2000
- Review
- 54 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 5 citing it directly.
- This deviceK001625 Pronova Nonabsorbable Suture, UspETHICON, Inc. · 2000
- Descendant · cites it directly · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- Descendant · 2 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- Descendant · 2 generations on · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- Descendant · 2 generations on · 41 of its ownK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- Descendant · 2 generations on · 32 of its ownK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · cites it directly44descendants
- K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 2 generations on43descendants
- K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · 2 generations on42descendants
- K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · 2 generations on41descendants
- K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · 2 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001625 | Pronova Nonabsorbable Suture, Usp | ETHICON, Inc. | 2000 | — |
| +1 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| +2 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| +2 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| +2 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| +2 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (49)
See all 495 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?
- Of its descendants, K013664 (Coalescent Surgical, 2002) has gone furthest, with 44 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.
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 | — |
https://510kreport.com/device/K001625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001625: Pronova Nonabsorbable Suture, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001625
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026