# K020428: Endopath Dilating Tip Trocar, Model #512XD

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 4, 2002 after 24 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have 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) ENDOPATH® Dilating Tip Trocar: named in the summary without a submission number
- (no number) ENDOPATH® Non-Bladed Obturator and Sleeve: named in the summary without a submission number

## Most influential descendants
- K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars (2005), 3 descendants of its own
- K062497: Reprocessed Trocars (2007), 2 descendants of its own
- K132629: Reprocessed Dilating Tip Trocars (2013), 0 descendants of its own
- K100080: Reprocessed Trocars, Model B5LT and CB5LT (2010), 0 descendants of its own
- K081398: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories (2009), 0 descendants of its own

## Indications for use
The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K020428
Methodology: https://510kreport.com/methodology