# K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jun 25, 1996 after 76 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
89 later devices descend from it; 5 cite it directly.
1 of 90 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K980023: Endopath and Proximate Linear Cutters (1998), 88 descendants of its own
- K020779: Proximate and Endopath Linear Cutters and Staplers (2002), 87 descendants of its own
- K030653: Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading Units with Reloads (2003), 46 descendants of its own
- K040398: Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads (2004), 45 descendants of its own
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM (2004), 25 descendants of its own

## Recalls of this device
- Nov 25, 2003 · Not classified · Z-0212-04: A defective articulation band may result in improper staple formation with possible hematosis.
- Nov 25, 2003 · Not classified · Z-0213-04: A defective articulation band may result in improper staple formation with possible hematosis.

## Indications for use
The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

Source page: https://510kreport.com/device/K961390
Methodology: https://510kreport.com/methodology