# K172097: Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Renovo, Inc.
- Decided: Oct 6, 2017 after 87 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: 2 generations back to K032676 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath, Ethicon Endo-Surgery, LLC (2012) Summary page 5.

## Indications for use
The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions. The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K172097
Methodology: https://510kreport.com/methodology