# K073046: Ethicon Endo Surgery Articulating Needle Knife, Model 2504

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Feb 25, 2008 after 119 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
Longest line of descent: 1 generation back to K970053 (1997). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972497: Karl Storz Monopolar Coagulating Electrodes/ Karl Storz Monopolar Coagulating Needle Electrodes, KARL STORZ Endoscopy-America, Inc. (1997) Summary page 1.
- K000348: Colorado Microdissection Needle, Stryker Leibinger (2000) Summary page 1.
- K970053: Ultratomerx, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K082955: Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 (2009), 2 descendants of its own
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 (2008), 2 descendants of its own
- K103155: Sumo Access and Tissue Resection System (2011), 0 descendants of its own
- K093279: Navix Access Device (2010), 0 descendants of its own
- K091824: Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507 (2009), 0 descendants of its own

## Indications for use
The Articulating Needle Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Articulating Needle Knife is not intended for use in the central nervous system or in the central circulatory system.

Source page: https://510kreport.com/device/K073046
Methodology: https://510kreport.com/methodology