510(k) · Cleared

Recalled · Class II · 2026

Modification to V-Loc 180 Absorbable Wound Closure Device

K091087510(k) SpecialCleared Apr 22, 20097-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

Surgical Devices, Tyco Healthcare Group LP · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Apr 22, 2009 as substantially equivalent to K082662 (Surgical Devices, Tyco Healthcare Group LP, 2009) after a 7-day review. Its family tree reaches back 2 generations to 1999. 27 later devices descend from it. It has been recalled once.

Decided: Apr 22, 2009
Review: 7 days
Class: Class II
Product code: GAM
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K990951 (1999). 3 ancestors in all. 27 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK990951 Maxon** Sterile, Synthetic, Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1999 · Recalled
1 generation backK082662 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009
This deviceK091087 Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009
Descendant · cites it directly · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
Descendant · 2 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
Descendant · 3 generations on · 18 of its ownK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
Descendant · 3 generations on · 11 of its ownK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
Descendant · 3 generations on · 10 of its ownK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009high 3 (2012) · low 0 (2016)2026

Most influential descendants

Showing 5 of 27 · See all

K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · cites it directly24descendants
K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 2 generations on19descendants
K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on18descendants
K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on11descendants
K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990951	Maxon** Sterile, Synthetic, Absorbable Suture	United States Surgical, A Division of Tyco Healthc	1999	1
−1	K082662	V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, Tyco Healthcare Group LP	2009	—
0 (this device)	K091087	Modification to V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, Tyco Healthcare Group LP	2009	—
+1	K100257	VLOC9ABSORBABLE Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	2010	1
+2	K122898	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. Dba Angiotech	2012	1
+3	K123409	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. Dba Angiotech	2012	—
+3	K123836	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. Dba Angiotech	2012	—
+3	K141778	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corporation	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	1	0
2012	3	0
2013	2	0
2014	1	0
2015	2	0
2018	1	0
2019	2	0
2020	1	0
2021	2	0
2022	3	0
2023	1	0
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K091087, 1999–2026Source: 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 14.8 · 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
*	K082662	V-Loc 180 Absorbable Wound Closure Device Summary page 1 …thetic Absorbable Suture CLASSIFICATION NAME: Polyglycolic Acid Absorbable Surgical Suture PREDICATE DEVICE(S): K082662 - V-ICcT M 180 Absorbable Wound Device DEVICE DESCRIPTION:…	Surgical Devices, Tyco Healthcare Group LP	2009	—

Also cleared against K082662: 2 other devices →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K100257	VLOC9ABSORBABLE Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	2010	24
K173874	StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO	Origami Surgical, LLC	2018	3
K111442	V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…	Covidien, Formerly US Surgical A Divison of Tyco H	2011	0
K093408	V-Loc 180 Absorbable Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2026	Class II	Z-2919-2026	Equipment maintenance	Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K100257 (Surgical Devices, A Division of Tyco Healthcare, 2010) has gone furthest, with 24 descendants of its own.
2 other devices also cite its predicate K082662.

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. 2009, this device’s year, is highlighted.

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?

V-LocTM 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091087: Modification to V-Loc 180 Absorbable Wound Closure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091087

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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