510(k) Report

510(k) · Cleared

Cleared

Polyviolene Suture-Revised Labeling

K926167510(k) TraditionalCleared Dec 17, 1993381-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

Look, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Dec 17, 1993 after a 381-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 144 later devices descend from it.

Decided
Dec 17, 1993
Review
381 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
0

144 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2004: 2 descendants cleared2005: 3 descendants cleared2019: 6 descendants cleared2017: 15 descendants cleared2015: 7 descendants cleared2009: 1 descendant cleared2007: 4 descendants cleared2018: 10 descendants cleared2013: 10 descendants cleared2008: 4 descendants cleared2010: 2 descendants cleared2006: 1 descendant cleared2012: 7 descendants cleared2011: 1 descendant cleared2014: 10 descendants cleared2022: 10 descendants cleared2024: 3 descendants cleared2023: 9 descendants cleared2016: 10 descendants cleared2020: 7 descendants cleared2026: 9 descendants cleared2021: 6 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK926167 Polyviolene Suture-Revised LabelingLook, Inc. · 1993
  2. Descendant · cites it directly · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  3. Descendant · 2 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  4. Descendant · 2 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
  5. Descendant · 3 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
  6. Descendant · 3 generations on · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

2003: 32004: 22005: 32006: 12007: 42008: 42009: 12010: 22011: 12012: 72013: 102014: 102015: 72016: 102017: 152018: 102019: 62020: 72021: 62022: 102023: 92024: 32025: 42026: 9
2003high 15 (2017) · low 1 (2006)2026

Most influential descendants

Showing 5 of 144 · See all
  • K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · cites it directly143descendants
  • K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on102descendants
  • K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 2 generations on77descendants
  • K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 3 generations on69descendants
  • K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · 3 generations on48descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926167Polyviolene Suture-Revised LabelingLook, Inc.1993—
+1K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
+2K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
+2K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2004—
+3K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple…Synovis Surgical Innovations2004—
+3K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with…Tyco Healthcare Group LP200824

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200420
200530
200610
200740
200840
200910
201020
201110
201270
2013100
2014100
201570
2016100
2017150
2018100
201960
202070
202160
2022100
202390
202430
202540
202690
FIG. 1 — Lineage of K926167, 1993–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143

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, K030782 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 143 descendants of its own.

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—

More from Look, Inc.

31 FDA decisions under this applicant name. See the company

  • K943949Polyviolene Surgicl SutureLook, Inc. · 1994
  • K933686Look Inc. 316L Stainless Steel Surgical SutureLook, Inc. · 1993
  • K926586Revised Labeling for Chromic and Plain Gut SuturesLook, Inc. · 1993
  • K926588Revised Labeling for Polypropylene SutureLook, Inc. · 1993
  • K926168Silk Sutures-Revised LabelingLook, Inc. · 1993

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/K926167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926167: Polyviolene Suture-Revised Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926167

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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