510(k) Report

510(k) · Cleared

Cleared

Demetech Polyester Nonabsorbable Suture

K023030510(k) TraditionalCleared Jun 18, 2003280-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Demetech Corp. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jun 18, 2003 as substantially equivalent to K003590 (Gramsmed, LLC, 2001) after a 280-day review. Its family tree reaches back 1 generation to 2001. 19 later devices descend from it.

Decided
Jun 18, 2003
Review
280 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003590 (2001). 19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2015: 1 descendant cleared2017: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 2 descendants clearedK003590 · Grams Polyester Nonabsorbable Suture · Gramsmed, LLC · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 3 descendants10 generations forward: 2 descendants K003590 · Grams Polyester Nonabsorbable Suture · Gramsmed, LLC · 20010+5+10
  1. Root · 1 generation backK003590 Grams Polyester Nonabsorbable SutureGramsmed, LLC · 2001
  2. This deviceK023030 Demetech Polyester Nonabsorbable SutureDemetech Corp. · 2003
  3. Descendant · cites it directly · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  4. Descendant · 2 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
  5. Descendant · 3 generations on · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
  6. Descendant · 4 generations on · 9 of its ownK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
  7. Descendant · 5 generations on · 8 of its ownK180010 AtriClip FLEX-VAtriCure, Inc. · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12014: 12015: 12016: 22017: 32018: 22019: 12021: 12022: 12023: 22026: 2
2010high 3 (2017) · low 0 (2011)2026

Most influential descendants

Showing 5 of 19 · See all
  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · cites it directly18descendants
  • K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 2 generations on15descendants
  • K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. · 2016 · 3 generations on10descendants
  • K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017 · 4 generations on9descendants
  • K180010AtriClip FLEX-VAtriCure, Inc. · 2018 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003590Grams Polyester Nonabsorbable SutureGramsmed, LLC2001—
0 (this device)K023030Demetech Polyester Nonabsorbable SutureDemetech Corp.2003—
+1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc.2010—
+2K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.2012—
+3K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.2016—
+4K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.2017—
+5K180010AtriClip FLEX-VAtriCure, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201410
201510
201620
201730
201820
201910
202110
202210
202320
202620
FIG. 1 — Lineage of K023030, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GAT? 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 GAT device

  1. #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003590Grams Polyester Nonabsorbable Suture
Summary page 1
…tic Surgery Clms: I1 (3) Legally marketedpredicate device: Grams Polyester Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No.: K003590) (4) Subject device description: The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually…
Gramsmed, LLC2001—

Also cleared against K003590: 3 other devices →

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018

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?

  • Its one ancestor has no recall.
  • Of its descendants, K093679 (AtriCure, Inc., 2010) has gone furthest, with 18 descendants of its own.
  • 3 other devices also cite its predicate K003590.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation andor ligation, including use in cardiovascular and ophthalmic and neurological procedures.

Indications for use as stated in the FDA summary.

Also cleared against K003590

3 other devices cite the same predicate.

  • K041553Arthrex Suture Grafting KitArthrex, Inc. · 2004
  • K021434Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  • K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001

More from Demetech Corp.

10 FDA decisions under this applicant name. See the company

  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
  • K123940Demequicktm (Rapid Absorbable) Synthetic Surgical SutureDemetech Corp. · 2014
  • K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013
  • K082097Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 2010
  • K072930Demetech Absorbable Surgical Suture Plain & Chromic GutDemetech Corp. · 2008

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K023030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023030: Demetech Polyester 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/K023030

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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