# K141007: Demesteel (Stainless Steel) Non-Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: Sep 25, 2014 after 160 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- 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 K930940 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933686: Look Inc. 316L Stainless Steel Surgical Suture, Look, Inc. (1993) Summary page 4.
- K930940: Lukens Stainless Steel Surgical Suture, Lukens Medical Corp. (1993) Summary page 4.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 4.

## Indications for use
“DemeSTEEL” is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, stemal closure and certain orthopedic procedures, including cerclage and tendon repair.

Source page: https://510kreport.com/device/K141007
Methodology: https://510kreport.com/methodology