# K012362: Modification to Vascular Closure Device

- Pathway: 510(k) (Special)
- Applicant: Std Mfg., Inc.
- Decided: Aug 23, 2001 after 29 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003169 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003169: Vascular Closure Device, Std Mfg., Inc. (2000) Summary page 2.

## Indications for use
The Vascular Closure Device (VCD) Indications for use is to approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wound or puncture sites to aid healing in minimally invasive or open procedures for full body applications.

Source page: https://510kreport.com/device/K012362
Methodology: https://510kreport.com/methodology