# K980022: Endopath Endoscopic Tissue Fastening System (Etfs)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 9, 1998 after 63 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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). 1 ancestor in all.
25 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972679: Endopath Endoscopic Tissue Fastening System (Etfs), Ethicon Endo-Surgery, Inc. (1997) Summary page 1.

## Most influential descendants
- K994290: Bard Endoscopic Suturing System (2000), 23 descendants of its own
- K062875: Endogastric Stomaphyx Device and Accessories (2007), 21 descendants of its own
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), 15 descendants of its own
- K092400: Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model 2.7.5 (2009), 6 descendants of its own
- K142113: ESOPHYX2 HD (2014), 5 descendants of its own

## Indications for use
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches. ETHIBOND EXCEL Polyester Suture is intended for usc in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K980022
Methodology: https://510kreport.com/methodology