510(k) Report

510(k) · Cleared

Cleared

Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures

K091574510(k) AbbreviatedCleared Oct 9, 2009129-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

Supplidores Unidos Internacionales, S.A. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Oct 9, 2009 as substantially equivalent to K001184 (Cp Medical, 2000) and 3 other predicates after a 129-day review. Its family tree reaches back 1 generation to 2000.

Decided
Oct 9, 2009
Review
129 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K001184 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 3 other ancestorsK001184 · Silk, Nonabsorbable, Surgical Sutures, Usp · Cp Medical · 2000200020022004200620082010
Other ancestors, by generation 1 generation back: 3 other ancestors K001184 · Silk, Nonabsorbable, Surgical Sutures, Usp · Cp Medical · 20000
  1. Root · 1 generation backK001184 Silk, Nonabsorbable, Surgical Sutures, UspCp Medical · 2000
  2. This deviceK091574 Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and…Supplidores Unidos Internacionales, S.A. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001184Silk, Nonabsorbable, Surgical Sutures, UspCp Medical2000—
0 (this device)K091574Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black…Supplidores Unidos Internacionales, S.A.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
FIG. 1 — Lineage of K091574, 2000–2009Source: 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? (4)

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
*K001184Silk, Nonabsorbable, Surgical Sutures, Usp
Summary page 1
…ative Device: CP Medical Non-absorbable Surgical Sutures :510.K Number . POdUctDe§:'itioni K001 184 Silk Non-absorbable Surgical Sutures K001173 Nylon Non-absorbable Surgical…
Cp Medical2000—
*K001173Nylon, Nonabsorbable Surgical Sutures Usp
Summary page 1
…:510.K Number . POdUctDe§:'itioni K001 184 Silk Non-absorbable Surgical Sutures K001173 Nylon Non-absorbable Surgical Sutures K001185 Polypropylene Non-absorbabl…
Cp Medical20001
*K001185Polypropylene, Nonabsorbable Surgical Sutures Usp
Summary page 1
…184 Silk Non-absorbable Surgical Sutures K001173 Nylon Non-absorbable Surgical Sutures K001185 Polypropylene Non-absorbable Surgical Sutures K001 172 Polyester Non-absor…
Cp Medical20001
*K001172Polyester Nonabsorbable Surgical Sutures Urp
Summary page 1
…Nylon Non-absorbable Surgical Sutures K001185 Polypropylene Non-absorbable Surgical Sutures K001 172 Polyester Non-absorbalbe surgical Sutures Modifications: There are no modifications to the device desig…
Cp Medical20001

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 3 of the 4 ancestors have a recall of any class.

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. 2009, this device’s year, is highlighted.

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?

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

Indications for use as stated in the FDA summary.

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/K091574 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091574: Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091574

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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