# K132629: Reprocessed Dilating Tip Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Dec 31, 2013 after 131 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- 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
Longest line of descent: 5 generations back to K940232 (1994). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062497: Reprocessed Trocars, Ascent Healthcare Solutions (2007) Summary page 1.
- K070059: Reprocessed Trocars, Ascent Healthcare Solutions (2007) Summary page 1.
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath, Ethicon Endo-Surgery, LLC (2012) Summary page 1.

## Indications for use
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establsh a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments. The Reprocessed Stability Sleeve 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/K132629
Methodology: https://510kreport.com/methodology