510(k) · Cleared
Recalled · 2011Nylon, Nonabsorbable Surgical Sutures Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jun 23, 2000 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2000
- Review
- 73 days
- Class
- Class II
- Product code
- GAR
- Recalls
- 1
- Predicates
- 0
23 later devices descend from it, 4 citing it directly.
- This deviceK001173 Nylon, Nonabsorbable Surgical Sutures UspCp Medical · 2000
- Descendant · cites it directly · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK153307 HS SutureTapeRiverpoint Medical · 2016
- Descendant · 2 generations on · 6 of its ownK190817 HS FiberRiverpoint Medical · 2019
- Descendant · 3 generations on · 3 of its ownK231163 HS Fiber SuturesRiverpoint Medical · 2024
- Descendant · cites it directly · 3 of its ownK041510 Trulon Non-Absorbable Polyamide Surgical SutureSutures India Private Limited · 2005
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · cites it directly15descendants
- K153307HS SutureTapeRiverpoint Medical · 2016 · 2 generations on7descendants
- K190817HS FiberRiverpoint Medical · 2019 · 2 generations on6descendants
- K231163HS Fiber SuturesRiverpoint Medical · 2024 · 3 generations on3descendants
- K041510Trulon Non-Absorbable Polyamide Surgical SutureSutures India Private Limited · 2005 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001173 | Nylon, Nonabsorbable Surgical Sutures Usp | Cp Medical | 2000 | — |
| +1 | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… | Riverpoint Medical | 2010 | 2 |
| +2 | K153307 | HS SutureTape | Riverpoint Medical | 2016 | — |
| +2 | K190817 | HS Fiber | Riverpoint Medical | 2019 | — |
| +3 | K231163 | HS Fiber Sutures | Riverpoint Medical | 2024 | — |
| +1 | K041510 | Trulon Non-Absorbable Polyamide Surgical Suture | Sutures India Private Limited | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 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? (23)
See all 234 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 | 15 |
| K041510 | Trulon Non-Absorbable Polyamide Surgical Suture | 2005 | 3 |
| K032160 | Artelon Surgical Suture | 2003 | 1 |
| K091574 | Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2011 | Not classified | Z-3177-2011 | Process control | Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100006 (Riverpoint Medical, 2010) has gone furthest, with 15 descendants of its own.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K001173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001173: Nylon, Nonabsorbable Surgical Sutures Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001173
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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