510(k) Report

510(k) · Cleared

Cleared

L-25 Absorbable Surigcal Suture

K013671510(k) AbbreviatedCleared Jan 8, 200263-day reviewClass II21 CFR 878.4493

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

United States Surgical, A Division of Tyco Healthc · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jan 8, 2002 as substantially equivalent to K885018 (United States Surgical, A Division of Tyco Healthc, 1989) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1989. 43 later devices descend from it.

Decided
Jan 8, 2002
Review
63 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K885018 (1989). 3 ancestors in all. 43 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1995: 1 other ancestor2003: 1 descendant cleared2004: 2 descendants cleared2005: 1 descendant cleared2018: 2 descendants cleared2007: 1 descendant cleared2014: 3 descendants cleared2019: 3 descendants cleared2023: 2 descendants cleared2026: 6 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2021: 3 descendants cleared2025: 3 descendants cleared2024: 4 descendants cleared2013: 2 descendants cleared2015: 2 descendants cleared2022: 3 descendants cleared2020: 1 descendant clearedK885018 · Absorbable Surgical Gut Suture* · United States Surgical, A Division of Tyco Healthc · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 9 descendants5 generations forward: 6 descendants6 generations forward: 6 descendants7 generations forward: 9 descendants8 generations forward: 1 descendant K885018 · Absorbable Surgical Gut Suture* · United States Surgical, A Division of Tyco Healthc · 19890+5
  1. Root · 1 generation backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
  2. This deviceK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
  3. Descendant · cites it directly · 29 of its ownK040477 MonodermSurgical Specialties Corp · 2004
  4. Descendant · 2 generations on · 28 of its ownK052437 Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005
  5. Descendant · 3 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
  6. Descendant · 4 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
  7. Descendant · 4 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12007: 12010: 12012: 32013: 22014: 32015: 22018: 22019: 32020: 12021: 32022: 32023: 22024: 42025: 32026: 6
2003high 6 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 43 · See all
  • K040477MonodermSurgical Specialties Corp · 2004 · cites it directly29descendants
  • K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005 · 2 generations on28descendants
  • K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 3 generations on26descendants
  • K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 4 generations on24descendants
  • K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 4 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K885018Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc1989—
0 (this device)K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc2002—
+1K040477MonodermSurgical Specialties Corp2004—
+2K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp2005—
+3K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp2007—
+4K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare20101
+4K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20121

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200710
201010
201230
201320
201430
201520
201820
201930
202010
202130
202230
202320
202440
202530
202660
FIG. 1 — Lineage of K013671, 1989–2026Source: 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 GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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? (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
*K885018Absorbable Surgical Gut Suture*
Summary page 1
…are Group, LP 150 Glover Avenue Norwalk, CT 06856 Robert Zott November 1, 2001 Absorbable poly(glycolide/L-lactide) surgical suture Surgical Suture To be determined K885018: Gut Suture (Surgigut™) K000037: Biosyn™ Suture K944110: Vicryl™ Rapide Suture The device is indicated for use in general soft t…
United States Surgical, A Division of Tyco Healthc1989—
*K000037Monofilament Biosyn Suture
Summary page 1
…Norwalk, CT 06856 Robert Zott November 1, 2001 Absorbable poly(glycolide/L-lactide) surgical suture Surgical Suture To be determined K885018: Gut Suture (Surgigut™) K000037: Biosyn™ Suture K944110: Vicryl™ Rapide Suture The device is indicated for use in general soft tissue approximation and/or ligat…
United States Surgical, A Division of Tyco Healthc200028
*K944110Vicryl Rapide Suture
Summary page 1
…rt Zott November 1, 2001 Absorbable poly(glycolide/L-lactide) surgical suture Surgical Suture To be determined K885018: Gut Suture (Surgigut™) K000037: Biosyn™ Suture K944110: Vicryl™ Rapide Suture The device is indicated for use in general soft tissue approximation and/or ligation, but not for use in…
ETHICON, Inc.19952

Also cleared against K885018: 1 other device →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K040477MonodermSurgical Specialties Corp200429
K032586Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc200312
K042141Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical200411

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?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K040477 (Surgical Specialties Corp, 2004) has gone furthest, with 29 descendants of its own.
  • 1 other device also cites its predicate K885018.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

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 K885018

1 other device cites the same predicate.

  • K142656Surgical Gut SutureCovidien · 20153 recalls

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K013671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013671: L-25 Absorbable Surigcal Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013671

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026