510(k) · Cleared

Recalled · 2009

Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture

K032420510(k) TraditionalCleared Oct 22, 200378-day reviewClass II21 CFR 878.4493Recalls 1

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 Oct 22, 2003 after a 78-day review. The FDA summary names its predicate without a number. 29 later devices descend from it. It has been recalled once.

Decided: Oct 22, 2003
Review: 78 days
Class: Class II
Product code: GAM
Recalls: 1
Predicates: 0

29 later devices descend from it, 3 citing it directly.

This deviceK032420 Modified Coated Vicryl Plus Antibacterial (Polyglactin 910)…ETHICON, Inc. · 2003
Descendant · cites it directly · 25 of its ownK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
Descendant · cites it directly · 21 of its ownK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
Descendant · 2 generations on · 8 of its ownK151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX…ETHICON, Inc. · 2015 · Recalled
Descendant · 2 generations on · 8 of its ownK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2005high 4 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 29 · See all

K050845Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · cites it directly25descendants
K061037PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · cites it directly21descendants
K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc. · 2015 · 2 generations on8descendants
K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015 · 2 generations on8descendants
K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032420	Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic…	ETHICON, Inc.	2003	—
+1	K050845	Monocryl Plus Antibacterial Suture	ETHICON, Inc.	2005	1
+1	K061037	PDS Plus Antibacterial Suture	ETHICON, Inc.	2006	9
+2	K151200	STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral…	ETHICON, Inc.	2015	1
+2	K150670	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device	ETHICON, Inc.	2015	—
+3	K182873	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral…	ETHICON, Inc.	2019	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2010	1	0
2011	1	0
2013	1	0
2014	3	0
2015	2	0
2018	2	0
2019	4	0
2020	2	0
2022	2	0
2024	2	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K032420, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.7 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture Named without a submission number			—

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K050845	Monocryl Plus Antibacterial Suture	ETHICON, Inc.	2005	25
K061037	PDS Plus Antibacterial Suture	ETHICON, Inc.	2006	21
K132580	Coated Vicryl Plus Antimicrobial (Polyglactin 910) Synthetic Absorbable Suture	ETHICON, Inc.	2014	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 2, 2009	Not classified	Z-1310-2009	Process control	Sterility 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, K050845 (ETHICON, Inc., 2005) has gone furthest, with 25 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

2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	50	10	274
2008	6	174	1	194
2009	3	10	6	287
2010	1	—	3	587
2011	2	—	6	637
2012	5	31	0	868
2013	1	—	0	898
2014	10	121	0	1,410
2015	5	209	0	935
2016	3	169	1	1,112
2017	8	134	1	1,499
2018	5	98	0	2,229
2019	4	90	1	3,564
2020	3	140	44	3,415
2021	2	—	0	4,506
2022	2	—	4	4,814
2023	1	—	0	5,070
2024	2	—	1	7,226
2025	3	29	0	8,970
2026	4	131	2	—

What is it indicated for?

Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032420: Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic 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/K032420

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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