510(k) Report

510(k) · Cleared

Cleared

V-Loc 180 Absorbable Wound Closure Device

K082662510(k) TraditionalCleared Mar 26, 2009195-day reviewClass II21 CFR 878.4493

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 Mar 26, 2009 as substantially equivalent to K990951 (United States Surgical, A Division of Tyco Healthc, 1999) and 1 other predicate after a 195-day review. Its family tree reaches back 1 generation to 1999. 34 later devices descend from it.

Decided
Mar 26, 2009
Review
195 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K990951 (1999). 2 ancestors in all. 34 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2011: 1 descendant cleared2012: 4 descendants cleared2009: 2 descendants cleared2010: 1 descendant cleared2018: 1 descendant cleared2013: 4 descendants cleared2020: 2 descendants cleared2015: 3 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2021: 2 descendants cleared2022: 3 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared2023: 1 descendant clearedK990951 · Maxon** Sterile, Synthetic, Absorbable Suture · United States Surgical, A Division of Tyco Healthc · 1999 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 11 descendants5 generations forward: 2 descendants K990951 · Maxon** Sterile, Synthetic, Absorbable Suture · United States Surgical, A Division of Tyco Healthc · 1999 · recalled0+5
  1. Root · 1 generation backK990951 Maxon** Sterile, Synthetic, Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1999 · Recalled
  2. This deviceK082662 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009
  3. Descendant · cites it directly · 27 of its ownK091087 Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · Recalled
  4. Descendant · cites it directly · 25 of its ownK113744 Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012
  5. Descendant · 2 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
  6. Descendant · 2 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
  7. Descendant · 2 generations on · 18 of its ownK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2009: 22010: 12011: 12012: 42013: 42014: 12015: 32016: 12018: 12019: 22020: 22021: 22022: 32023: 12024: 22025: 22026: 2
2009high 4 (2012) · low 0 (2017)2026

Most influential descendants

Showing 5 of 34 · See all
  • K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 2009 · cites it directly27descendants
  • K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012 · cites it directly25descendants
  • K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 2 generations on24descendants
  • 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 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990951Maxon** Sterile, Synthetic, Absorbable SutureUnited States Surgical, A Division of Tyco Healthc19991
0 (this device)K082662V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP2009—
+1K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP20091
+1K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech2012—
+2K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare20101
+2K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20121
+2K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201010
201110
201240
201340
201410
201530
201610
201810
201920
202020
202120
202230
202310
202420
202520
202620
FIG. 1 — Lineage of K082662, 1999–2026Source: 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 14.7 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K990951Maxon** Sterile, Synthetic, Absorbable Suture
Summary page 1
…Absorbable Suture CLASSIFICATION NAME: Polyglycolic Acid Absorbable Surgical Suture PREDICATE DEVICE(S): SynetureTM MaxonTM Synthetic Absorbable Suture (K990951) Quill TM Synthetic Absorbable Barbed Suture (K042075) DEVICE DESCRIPTION: The V-LocTM 180…
United States Surgical, A Division of Tyco Healthc19991
*K042075Quill Synthetic Absorbable Barbed Suture
Summary page 1
…al Suture PREDICATE DEVICE(S): SynetureTM MaxonTM Synthetic Absorbable Suture (K990951) Quill TM Synthetic Absorbable Barbed Suture (K042075) DEVICE DESCRIPTION: The V-LocTM 180 Absorbable Wound Closure Device is a suture prepared fr…
Quill Medical, Inc.2004—

Also cleared against K990951: 3 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP200927
K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech201225
K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20110

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K091087 (Surgical Devices, Tyco Healthcare Group LP, 2009) has gone furthest, with 27 descendants of its own.
  • 3 other devices also cite its predicate K990951.

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

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?

V-LocTM 180 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Indications for use as stated in the FDA summary.

Also cleared against K990951

3 other devices cite the same predicate.

  • K211792StitchKitOrigami Surgical Inc . · 2021
  • K093408V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 20091 recall
  • K041515Truglyde Absorbable Polyglycolic Acid Surgical SutureSutures India Private Limited · 2005

More from Surgical Devices, Tyco Healthcare…

2 FDA decisions under this applicant name. See the company

  • K091087Modification to V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, Tyco Healthcare Group LP · 20091 recall

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/K082662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082662: V-Loc 180 Absorbable 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/K082662

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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