510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Coated Vicryl* (Polyglactin 910) Suture

K022269510(k) TraditionalCleared Sep 13, 200260-day reviewClass II21 CFR 878.4493Recalls 3

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

ETHICON, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Sep 13, 2002 after a 60-day review. The FDA summary names its predicate without a number. 108 later devices descend from it. It has been recalled 3 times.

Decided
Sep 13, 2002
Review
60 days
Class
Class II
Product code
GAM
Recalls
3
Predicates
0

108 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2012: 10 descendants cleared2015: 6 descendants cleared2008: 5 descendants cleared2016: 3 descendants cleared2013: 8 descendants cleared2006: 7 descendants cleared2017: 5 descendants cleared2005: 5 descendants cleared2014: 5 descendants cleared2004: 1 descendant cleared2025: 5 descendants cleared2026: 4 descendants cleared2009: 4 descendants cleared2007: 3 descendants cleared2018: 6 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2019: 7 descendants cleared2020: 6 descendants cleared2021: 3 descendants cleared2022: 4 descendants cleared2024: 4 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK022269 Coated Vicryl* (Polyglactin 910) SutureETHICON, Inc. · 2002
  2. Descendant · cites it directly · 68 of its ownK024117 Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  4. Descendant · 3 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  5. Descendant · 3 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  6. Descendant · 3 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2003: 32004: 12005: 52006: 72007: 32008: 52009: 42010: 12011: 22012: 102013: 82014: 52015: 62016: 32017: 52018: 62019: 72020: 62021: 32022: 42023: 12024: 42025: 52026: 4
2003high 10 (2012) · low 1 (2004)2026

Most influential descendants

Showing 5 of 108 · See all
  • K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · cites it directly68descendants
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · 2 generations on64descendants
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 3 generations on31descendants
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 3 generations on30descendants
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022269Coated Vicryl* (Polyglactin 910) SutureETHICON, Inc.2002—
+1K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc.20031
+2K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
+3K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—
+3K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp2008—
+3K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200410
200550
200670
200730
200850
200940
201010
201120
2012100
201380
201450
201560
201630
201750
201860
201970
202060
202130
202240
202310
202440
202550
202640
FIG. 1 — Lineage of K022269, 2002–2026Source: 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? (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
*—Coated VICRYL (Polyglactin 910) Synthetic Absorbable Suture
Named without a submission number
—

What descends from it? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc.200368
K030594I-125 Rapid Strand, Model 7000Amersham Health200317
K122734Aesculap Novosyn Absorbable SutureAesculap, Inc.20125
K060367TenoligFournitures Hospitalieres Industrie20063
K120556Vilet Vilet QuickRiverpoint Medical20122
K072859Atramat PGLA90 Poly (Glycolide-CO-L-Lactide) Surgical SuturesInternacional Farmaceutica, S.A. DE C.V.20081
K062366Optime, Sinusorb PgaPeters Surgical20061
K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing)…Cpt Sutures Co., Ltd.20170
K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…Ethicon, LLC20160
K142822PLIASURE Polyglycolide Synthetic Absorbable SutureETHICON, Inc.20150

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

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2024Class IIZ-2144-2024Under Investigation by firmIssue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Jan 3, 2020Class IIZ-0989-2020Process controlSome sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
May 4, 2006Not classifiedZ-1087-06OtherMisalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K024117 (Incisive Surgical, Inc., 2003) has gone furthest, with 68 descendants of its own.

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?

Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Indications for use as stated in the FDA summary.

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 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/K022269 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022269: Coated Vicryl* (Polyglactin 910) Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022269

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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