510(k) Report

510(k) · Cleared

Cleared

Demesteel (Stainless Steel) Non-Absorbable Suture

K141007510(k) TraditionalCleared Sep 25, 2014160-day reviewClass II21 CFR 878.4495

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

Demetech Corp. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Cleared on Sep 25, 2014 as substantially equivalent to K933686 (Look, Inc., 1993) and 2 other predicates after a 160-day review. Its family tree reaches back 1 generation to 1993.

Decided
Sep 25, 2014
Review
160 days
Class
Class II
Product code
GAQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K930940 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1993: 1 other ancestorK930940 · Lukens Stainless Steel Surgical Suture · Lukens Medical Corp. · 1993199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K930940 · Lukens Stainless Steel Surgical Suture · Lukens Medical Corp. · 19930
  1. Root · 1 generation backK930940 Lukens Stainless Steel Surgical SutureLukens Medical Corp. · 1993
  2. This deviceK141007 Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930940Lukens Stainless Steel Surgical SutureLukens Medical Corp.1993—
0 (this device)K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
FIG. 1 — Lineage of K141007, 1993–2014Source: 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 GAQ? 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 GAQ device

  1. #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K933686Look Inc. 316L Stainless Steel Surgical Suture
Summary page 4
…Steel Non-absorbable Suture (DemeSTEEL) is substantially equivalent to these predicate devices: e Look Inc., 316L Stainless Steel surgical sutures reference 510K number K933686, Look Inc. Lonnie Abbott Ind. Blvd. Ada OK 74820 e Lukens Medical Corp. Stainless Steel Suture, reference 510K number K930940 v…
Look, Inc.1993—
*K930940Lukens Stainless Steel Surgical Suture
Summary page 4
…el surgical sutures reference 510K number K933686, Look Inc. Lonnie Abbott Ind. Blvd. Ada OK 74820 e Lukens Medical Corp. Stainless Steel Suture, reference 510K number K930940 via the Lahr Group Mahwah, NJ. e Ethicon’s, Stainless Steel Suture reference 510K number, K931271, Ethicon Inc. Somerville NJ.…
Lukens Medical Corp.1993—
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 4
…e Lukens Medical Corp. Stainless Steel Suture, reference 510K number K930940 via the Lahr Group Mahwah, NJ. e Ethicon’s, Stainless Steel Suture reference 510K number, K931271, Ethicon Inc. Somerville NJ. 71 K141007 page 2 of 4 F. Device Description: Demetech’s DemeSTEEL is a Monofila…
ETHICON, Inc.1994—

Also cleared against K933686: 1 other device →

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?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K933686.

How does its category compare?

All GAQ devices

GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GAQ

1in 2022

2007: 12008: 22014: 22017: 12018: 12020: 12022: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAQ

Too few GAQ 510(k)s in any year since 2007 to give a median.

Recalls per year · GAQ

2so far in 2026, the most since 2007

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

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

Adverse event reports per year · GAQ

83in 2025

2007: 72008: 42009: 72010: 132011: 192012: 102013: 162014: 182015: 172016: 232017: 112018: 532019: 762020: 522021: 392022: 702023: 1002024: 1762025: 83
2007high 176 (2024) · low 4 (2008)2025

MAUDE reports naming product code GAQ, 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
20082—04
20090—07
20100—013
20110—019
20120—010
20130—016
20142—018
20150—017
20160—023
20171—011
20181—053
20190—076
20201—052
20210—039
20221—070
20230—0100
20240—0176
20250—083
20260—2—

What is it indicated for?

“DemeSTEEL” is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, stemal closure and certain orthopedic procedures, including cerclage and tendon repair.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K933686

1 other device cites the same predicate.

  • K030926Fast Throw Stainless Steel Surgical SutureAdvanced Surgical Products, Inc. · 2003

More from Demetech Corp.

10 FDA decisions under this applicant name. See the company

  • 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
  • K043330Polypropilene Surgical SuturesDemetech Corp. · 2005

Recent decisions in GAQ

The GAQ category page

  • K203855CoNextions TR Tendon Repair SystemConextions Medical · 2022
  • K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd. · 2020
  • K172146MeristeelM/s. Meril Endo Surgery Private Limited. · 2018
  • K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. · 2017
  • K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014

https://510kreport.com/device/K141007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141007: Demesteel (Stainless Steel) Non-Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141007

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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