# K090419: Sils Stitch Endoscopic Suturing Device

- Pathway: 510(k) (Special)
- Applicant: Covidien Lp, Formerly Registered AS United States
- Decided: Mar 9, 2009 after 19 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934738 (1994). 2 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082659: Modified Endo Stich, Covidien Lp, Formerly Registered AS United States (2008) Summary page 1.

## Most influential descendants
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own
- K192720: GIA Stapler with Tri-Staple Technology (2020), 3 descendants of its own

## Indications for use
The SILS TM Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

Source page: https://510kreport.com/device/K090419
Methodology: https://510kreport.com/methodology