510(k) · Cleared
ClearedGrams Nylon Nonabsorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gramsmed, LLC · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Dec 18, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 18, 2000
- Review
- 83 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK003000 Grams Nylon Nonabsorbable SutureGramsmed, LLC · 2000
- Descendant · cites it directly · 1 of its ownK032160 Artelon Surgical SutureArtimplant AB · 2003
- Descendant · cites it directly · 0 of its ownK052900 Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK052482 Artelon Surgical SutureArtimplant AB · 2005
- Descendant · cites it directly · 0 of its ownK023028 Demetech Nylon Nonabsorbable SutureDemetech Corp. · 2003
Most influential descendants
Showing 4 of 4 · See all- K032160Artelon Surgical SutureArtimplant AB · 2003 · cites it directly1descendant
- K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc. · 2005 · cites it directly0descendants
- K052482Artelon Surgical SutureArtimplant AB · 2005 · 2 generations on0descendants
- K023028Demetech Nylon Nonabsorbable SutureDemetech Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003000 | Grams Nylon Nonabsorbable Suture | Gramsmed, LLC | 2000 | — |
| +1 | K032160 | Artelon Surgical Suture | Artimplant AB | 2003 | — |
| +1 | K052900 | Quill Nonabsorbable Nylon Barbed Suture | Quill Medical, Inc. | 2005 | — |
| +2 | K052482 | Artelon Surgical Suture | Artimplant AB | 2005 | — |
| +1 | K023028 | Demetech Nylon Nonabsorbable Suture | Demetech Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 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? (4)
3 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, K032160 (Artimplant AB, 2003) has gone furthest, with 1 descendant 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/K003000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003000: Grams Nylon Nonabsorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003000
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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