# K961264: Endopath EZ-RF Linear Cutter and Coagulation

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jul 19, 1996 after 108 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- 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; 1 cites 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 its predicate without a number.
- (no number) ELC Predicate Device: named in the summary without a submission number
- (no number) Forceps Predicate Device: named in the summary without a submission 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

## Indications for use
The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.

Source page: https://510kreport.com/device/K961264
Methodology: https://510kreport.com/methodology