# K033591: Reprocessed Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Jun 3, 2005 after 568 days
- Product code: KBG (Trocar, Sinus)
- Device class: 1
- Regulation: 21 CFR 874.4420
- 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 K011257 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020428: Endopath Dilating Tip Trocar, Model #512XD, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.
- K011538: Endopath Non-Bladed Solid Obturator Trocar System, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K011257: Endopath Non-Bladed Obturator Trocar System (5 MM), Ethicon Endo-Surgery, Inc. (2001) Summary page 1.

## Indications for use
The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Source page: https://510kreport.com/device/K033591
Methodology: https://510kreport.com/methodology