# K093408: V-Loc 180 Absorbable  Wound Closure Device

- Pathway: 510(k) (Special)
- Applicant: Surgical Devices, A Division of Tyco Healthcare
- Decided: Nov 12, 2009 after 10 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: 9 generations back to K014153 (2002). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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). 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”.
- K990951: Maxon** Sterile, Synthetic, Absorbable Suture, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo), Surgical Specialties Corp (2008) Summary page 1.

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2919-2026: 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 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K093408
Methodology: https://510kreport.com/methodology