# K061770: Ethicon Endo Surgery Endoscopic Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Sep 25, 2006 after 94 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 K972679 (1997). 3 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 1.
- K972679: Endopath Endoscopic Tissue Fastening System (Etfs), Ethicon Endo-Surgery, Inc. (1997) Summary page 1.
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001)

## Most influential descendants
- K081853: Overstitch Endoscopic Suture System (2008), 8 descendants of its own
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (2017), 7 descendants of its own
- K070151: Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier (2007), 4 descendants of its own
- K181141: OverStitch Endoscopic Suturing System and Accessories (2018), 3 descendants of its own
- K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge (2008), 3 descendants of its own

## Indications for use
The Ethicon Endo Surgery® Endoscopic Suturing System is indicated for endoscopic placement of suture(s) and approximation of soft tissue.

Source page: https://510kreport.com/device/K061770
Methodology: https://510kreport.com/methodology