510(k) · Cleared

Cleared

V-Loc (TM) Nonabsorbable Wound Closure Device

K103052510(k) TraditionalCleared Nov 10, 201027-day reviewClass II21 CFR 878.5000

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

Covidien, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Nov 10, 2010 as substantially equivalent to K990952 (United States Surgical, A Division of Tyco Healthc, 1999) after a 27-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.

Decided: Nov 10, 2010
Review: 27 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K990952 (1999). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK990952 Novafil** and Vascufil** Sterile Synthetic Non-Absorbable SuturesUnited States Surgical, A Division of Tyco Healthc · 1999 · Recalled
This deviceK103052 V-Loc (TM) Nonabsorbable Wound Closure DeviceCovidien, LLC · 2010
Descendant · cites it directly · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
Descendant · 2 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
Descendant · cites it directly · 0 of its ownK111442 V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K211792StitchKitOrigami Surgical Inc . · 2021 · cites it directly1descendant
K221527StitchKitOrigami Surgical Inc . · 2023 · 2 generations on0descendants
K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990952	Novafil and Vascufil Sterile Synthetic Non-Absorbable Sutures	United States Surgical, A Division of Tyco Healthc	1999	2
0 (this device)	K103052	V-Loc (TM) Nonabsorbable Wound Closure Device	Covidien, LLC	2010	—
+1	K211792	StitchKit	Origami Surgical Inc .	2021	—
+2	K221527	StitchKit	Origami Surgical Inc .	2023	—
+1	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	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K103052, 1999–2023Source: 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 GAT? 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 GAT device

#1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K990952	Novafil and Vascufil Sterile Synthetic Non-Absorbable Sutures Summary page 1 …Nonabsorbable poly(ethylene terephthalate) surgical suture PREDICATE DEVICE(S): Syneture Tm Novafl TM Synthetic Absorbable Suture (K990952) V-LocT 180 Absorbable Wound Closure Device (K090348) DEVICE DESCRIPTION:…	United States Surgical, A Division of Tyco Healthc	1999	2
Kept off the family tree	K090348	FDA’s K090348 is Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set Our reading of the summary gave K090348, FDA’s number for Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear… (Codman & Shurtleff, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “V-Loc 180 Absorbable Wound Closure Device”. Kept off the family tree. Summary page 1 …Syneture Tm Novafl TM Synthetic Absorbable Suture (K990952) V-LocT 180 Absorbable Wound Closure Device (K090348) DEVICE DESCRIPTION: The V-LoCTm Nonabsorbable Wound Closure Device is a polybutester…	Codman & Shurtleff, Inc.	2009	—

Also cleared against K990952: 1 other device →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K211792	StitchKit	Origami Surgical Inc .	2021	1
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

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?

Its one ancestor has a recall.
Of its descendants, K211792 (Origami Surgical Inc ., 2021) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K990952.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, 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	6	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

What is it indicated for?

V-LOC Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103052 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103052: V-Loc (TM) Nonabsorbable Wound Closure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103052

Report an extraction error

Are you the manufacturer?

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