# K100257: VLOC9ABSORBABLE Wound Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Devices, A Division of Tyco Healthcare
- Decided: May 10, 2010 after 102 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K014153 (2002). 28 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091087: Modification to V-Loc 180 Absorbable Wound Closure Device, Surgical Devices, Tyco Healthcare Group LP (2009) Summary page 1.
- K000037: Monofilament Biosyn Suture, United States Surgical, A Division of Tyco Healthc (2000) Summary page 1.
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm, Surgical Specialties Corp (2007) Summary page 1.

## Most influential descendants
- K122898: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 19 descendants of its own
- K123409: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 18 descendants of its own
- K123836: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 11 descendants of its own
- K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2014), 10 descendants of its own
- K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (2015), 8 descendants of its own

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2918-2026: 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 ophthalm

## Indications for use
V-LoCTM 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K100257
Methodology: https://510kreport.com/methodology