# K994087: Superstitch

- Pathway: 510(k) (Traditional)
- Applicant: Sutura, Inc.
- Decided: Mar 1, 2000 after 89 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: 1 generation back to K925149 (1993). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K963965: CTS Midcab Stitcher, Cardiothoracic Systems, Inc. (1998) Summary page 4.
- K934738: Autosuture Endoscopic Suturing Device, United States Surgical, A Division of Tyco Healthc (1994) Summary page 4.
- K925149: Auto Suture Endoscopic Knot Pusher, United States Surgical, A Division of Tyco Healthc (1993) Summary page 4.

## Most influential descendants
- K012865: Superstitch Vascular Suturing Device (2001), 1 descendant of its own
- K020940: Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00X (2002), 0 descendants of its own

## Indications for use
SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

Source page: https://510kreport.com/device/K994087
Methodology: https://510kreport.com/methodology