510(k) Report

510(k) · Cleared

Cleared

Truesilk Non-Absorbable Silk Surgical Suture

K041514510(k) TraditionalCleared Jun 3, 2005361-day reviewClass II21 CFR 878.5030

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

Sutures India Private Limited · GAP Suture, Nonabsorbable, Silk

Cleared on Jun 3, 2005 as substantially equivalent to K990089 (Aesculap, Inc., 1999) and 1 other predicate after a 361-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it.

Decided
Jun 3, 2005
Review
361 days
Class
Class II
Product code
GAP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K960328 (1996). 2 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2016: 1 descendant cleared2008: 1 descendant cleared2023: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant clearedK960328 · Silk Nonabsorbable Surgical Sutures Usp · R. K. Medical L. L. C. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants K960328 · Silk Nonabsorbable Surgical Sutures Usp · R. K. Medical L. L. C. · 19960
  1. Root · 1 generation backK960328 Silk Nonabsorbable Surgical Sutures UspR. K. Medical L. L. C. · 1996
  2. This deviceK041514 Truesilk Non-Absorbable Silk Surgical SutureSutures India Private Limited · 2005
  3. Descendant · cites it directly · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
  4. Descendant · 2 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
  5. Descendant · cites it directly · 2 of its ownK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
  6. Descendant · 2 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
  7. Descendant · 3 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2008: 12015: 12016: 12017: 22018: 22022: 12023: 32024: 2
2008high 3 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · cites it directly9descendants
  • K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 2 generations on4descendants
  • K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2016 · cites it directly2descendants
  • K173747RexleneSm Eng Co., Ltd. · 2018 · 2 generations on1descendant
  • K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960328Silk Nonabsorbable Surgical Sutures UspR. K. Medical L. L. C.1996—
0 (this device)K041514Truesilk Non-Absorbable Silk Surgical SutureSutures India Private Limited2005—
+1K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.2008—
+2K161633Rexlon, RexsilSm Eng Co., Ltd.2017—
+1K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non…M/s. Meril Endo Surgery Private Limited.2016—
+2K173747RexleneSm Eng Co., Ltd.2018—
+3K180701SafePath Suturing SystemSafepath Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201510
201610
201720
201820
202210
202330
202420
FIG. 1 — Lineage of K041514, 1996–2024Source: 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 GAP? 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 GAP device

  1. #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 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? (2)

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
*K990089Silkam Nonabsorbable Silk Surgical Suture
Summary page 1
…d Silk) * Classification Name :Natural Nonabsorbable Silk Surgical Suture. E. PREDIACATE DFVICES *Silkam Nonabsorbablc Surgical Suture, 510(k) Number K990089, AESCULAP, SOL11If Sa1n Frau.si sco, CaIlifo~rnia. *Silk Nonabsorbable Surgical Suture, 510(k) Number K960328. R…
Aesculap, Inc.1999—
*K960328Silk Nonabsorbable Surgical Sutures Usp
Summary page 1
…nabsorbablc Surgical Suture, 510(k) Number K990089, AESCULAP, SOL11If Sa1n Frau.si sco, CaIlifo~rnia. *Silk Nonabsorbable Surgical Suture, 510(k) Number K960328. R.K.Medical L.L.C. Danbury, CT0681I…
R. K. Medical L. L. C.1996—

Also cleared against K990089: 1 other device →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20089
K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited.20162

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K080684 (Foosin Medical Supplies, Inc., 2008) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K990089.

How does its category compare?

All GAP devices

GAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAP

3in 2024

2007: 12008: 12016: 22017: 12018: 12023: 12024: 3
2007high 3 (2024) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAP

193in 2024

2024: 193 days median
2007high 193 (2024)2026

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

Recalls per year · GAP

1in 2023

2011: 212014: 12018: 12023: 1
2007high 21 (2011) · low 0 (2007)2026

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

Adverse event reports per year · GAP

478in 2025

2007: 72008: 212009: 122010: 242011: 62012: 82013: 32014: 152015: 252016: 542017: 552018: 3402019: 3332020: 4262021: 4372022: 4192023: 4042024: 4552025: 478
2007high 478 (2025) · low 3 (2013)2025

MAUDE reports naming product code GAP, 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
20071—07
20081—021
20090—012
20100—024
20110—216
20120—08
20130—03
20140—115
20150—025
20162—054
20171—055
20181—1340
20190—0333
20200—0426
20210—0437
20220—0419
20231—1404
202431930455
20250—0478
20260—0—

What is it indicated for?

TRUSILK Non-absorbable Silk Surgical Suture is indicated for use in soft tissue

approximation and/or ligation including use in cardiovascular, ophthalmic and

neurological procedures.

Indications for use as stated in the FDA summary.

Also cleared against K990089

1 other device cites the same predicate.

  • K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015

More from Sutures India Private Limited

5 FDA decisions under this applicant name. See the company

  • K041511Trulene Non-Absorbable Polypropylene Surgical SutureSutures India Private Limited · 2005
  • K041510Trulon Non-Absorbable Polyamide Surgical SutureSutures India Private Limited · 2005
  • K041512Nonabsorbable (Polyethylene Terephthalate) Surgical SutureSutures India Private Limited · 2005
  • K041515Truglyde Absorbable Polyglycolic Acid Surgical SutureSutures India Private Limited · 2005

Recent decisions in GAP

The GAP category page

  • K241486Sofsilk™ Coated Braided Silk SutureCovidien · 2024
  • K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing…Safepath Medical, Inc. · 2024
  • K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024
  • K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd. · 2023
  • K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018

https://510kreport.com/device/K041514 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041514: Truesilk Non-Absorbable Silk Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041514

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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