510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)

K960653510(k) TraditionalCleared Mar 28, 199642-day reviewClass II21 CFR 878.4830Recalls 2

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

ETHICON, Inc. · GAN Suture, Absorbable, Synthetic

Cleared on Mar 28, 1996 after a 42-day review. The FDA summary names its predicate without a number. 193 later devices descend from it. It has been recalled 2 times.

Decided
Mar 28, 1996
Review
42 days
Class
Class II
Product code
GAN
Recalls
2
Predicates
0

193 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2007: 6 descendants cleared2008: 5 descendants cleared2010: 4 descendants cleared2015: 11 descendants cleared2005: 4 descendants cleared2002: 2 descendants cleared2013: 13 descendants cleared2003: 3 descendants cleared2020: 9 descendants cleared2006: 2 descendants cleared2012: 10 descendants cleared2014: 14 descendants cleared2019: 10 descendants cleared2024: 6 descendants cleared2004: 2 descendants cleared2022: 14 descendants cleared2011: 2 descendants cleared2018: 12 descendants cleared2026: 12 descendants cleared2017: 15 descendants cleared2009: 1 descendant cleared2021: 8 descendants cleared2025: 8 descendants cleared2023: 10 descendants cleared2016: 10 descendants cleared1995200020052010201520202025
  1. This deviceK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996
  2. Descendant · cites it directly · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
  3. Descendant · 2 generations on · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  4. Descendant · 3 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  5. Descendant · 3 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
  6. Descendant · 4 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004

Showing 5 of 193 descendants. See all descendants

Descendants cleared per year

2002: 22003: 32004: 22005: 42006: 22007: 62008: 52009: 12010: 42011: 22012: 102013: 132014: 142015: 112016: 102017: 152018: 122019: 102020: 92021: 82022: 142023: 102024: 62025: 82026: 12
2002high 15 (2017) · low 1 (2009)2026

Most influential descendants

Showing 5 of 193 · See all
  • K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · cites it directly145descendants
  • K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on143descendants
  • K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 3 generations on102descendants
  • K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 3 generations on77descendants
  • K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 4 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960653Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc.1996—
+1K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002—
+2K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
+3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
+3K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2004—
+4K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple…Synovis Surgical Innovations2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200330
200420
200540
200620
200760
200850
200910
201040
201120
2012100
2013130
2014140
2015110
2016100
2017150
2018120
2019100
202090
202180
2022140
2023100
202460
202580
2026120
FIG. 1 — Lineage of K960653, 1996–2026Source: 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 GAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

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
*—MONOCRYL (poliglecaprone 25) suture, dyed
Named without a submission number
—

What descends from it? (193)

See all 193

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

NumberDeviceApplicantDecidedDescendants
K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145
K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726
K050845Monocryl Plus Antibacterial SutureETHICON, Inc.200525
K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical20105
K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp.20131
K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH20150
K072863Atramat PGC25 Poly (Glycolide-CO-Epsilon-Caprolactone) Surgical SuturesInternacional Farmaceutica, S.A. DE C.V.20080
K072229MonoswiftCp Medical20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2024Class IIZ-2148-2024Under Investigation by firmIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Feb 2, 2009Not classifiedZ-1311-2009Process controlSterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K014183 (J&J Corporate Biomaterials Center, 2002) has gone furthest, with 145 descendants of its own.

How does its category compare?

All GAN devices

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

FDA decisions per year · GAN

FDA has decided no GAN device since 2007.

Median 510(k) review, days · GAN

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

Recalls per year · GAN

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · GAN

410in 2025

2007: 862008: 1242009: 672010: 232011: 622012: 1572013: 1032014: 922015: 762016: 632017: 672018: 4002019: 4342020: 2782021: 3012022: 3272023: 3432024: 4502025: 410
2007high 450 (2024) · low 23 (2010)2025

MAUDE reports naming product code GAN, 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
20070—086
20080—0124
20090—067
20100—023
20110—062
20120—0157
20130—0103
20140—092
20150—076
20160—063
20170—067
20180—0400
20190—0434
20200—0278
20210—0301
20220—0327
20230—0343
20240—1450
20250—0410
20260—0—

What is it indicated for?

MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, 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.

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

Recent decisions in GAN

The GAN category page

  • K003015Ssc's PCL Monofilament Sas, Violet, Coated, Model TBDSurgical Specialties Corp · 2000
  • K964072Monocryl (Poliglecaprone 25) Suture, UndyedETHICON, Inc. · 19962 recalls
  • K951231Orthopedic PacksSterile Concepts, Inc. · 1995
  • K920978Ula (Poliglecaprone 251) Synthetic Absor Sut, DyedETHICON, Inc. · 1994
  • K895579Polysorb Synthetic Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1990

https://510kreport.com/device/K960653 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960653

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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