# K011105: Suturtek Fastclose Fascia Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Qrc Consulting
- Decided: May 30, 2001 after 49 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030227: Suturtek Fastclose Suturing Device (2003), 2 descendants of its own
- K032468: Suturtek Fastclose Sternum Closure Device (2003), 1 descendant of its own
- K082828: Suturtek 360 Degree Sternal Closure Device (2008), 0 descendants of its own
- K063462: Neatstitch Neatclose Suturing Device (2007), 0 descendants of its own
- K042897: Autobahn Tissue Closure Device and Disposable Cartridge (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K011105
Methodology: https://510kreport.com/methodology