# K030227: Suturtek Fastclose Suturing Device

- Pathway: 510(k) (Traditional)
- Applicant: Suturtek Incorporated
- Decided: Mar 17, 2003 after 54 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
Longest line of descent: 1 generation back to K011105 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011105: Suturtek Fastclose Fascia Closure Device, Qrc Consulting (2001)

## Most influential descendants
- 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

## Indications for use
The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures. The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures. It is designed to aid in the prevention of suture needle stick injuries.

Source page: https://510kreport.com/device/K030227
Methodology: https://510kreport.com/methodology