510(k) · Cleared
Recalled · Class II · 2026V-Loc 180 Absorbable Wound Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Devices, A Division of Tyco Healthcare · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Nov 12, 2009 as substantially equivalent to K091087 (Surgical Devices, Tyco Healthcare Group LP, 2009) and 2 other predicates after a 10-day review. Its family tree reaches back 9 generations to 2002. It has been recalled once.
- Decided
- Nov 12, 2009
- Review
- 10 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K014153 (2002). 21 ancestors in all, the oldest K915489 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations between
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK093408 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2009
Show all 9 generations
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 7 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 6 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 5 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 4 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK093408 V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −8 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −7 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −6 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −5 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −4 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −3 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −2 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| −1 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| 0 (this device) | K093408 | V-Loc 180 Absorbable Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K091087 | Modification to V-Loc 180 Absorbable Wound Closure Device Our reading of the summary gave K091807, FDA’s number for Medpor Fixation System (Porex Surgical, Inc.), decided Jun 28, 2010, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “V-Loc 180 Absorbable Wound Closure Device”. | 2009 |
| * | K990951 | Maxon** Sterile, Synthetic, Absorbable SutureSummary page 1…K091807 2) Syneture TM MaxonTM Synthetic Absorbable Suture, K990951 3) QuillTM Self-Retaining (SRS) comprised of PDO… | 1999 |
| * | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Summary page 1…3) QuillTM Self-Retaining (SRS) comprised of PDO (Polydioxoanone), K080985 DEVICE DESCRIPTION: The V-Loc TM 180 absorbable wound closure device… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 21 ancestors have a recall of any class.
- 3 other devices also cite its predicate K091087.
How does its category compare?
All GAM devicesGAM 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 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/K093408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093408: 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/K093408
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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