# K153258: Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings (Dba Medline Renewal
- Decided: Apr 5, 2016 after 147 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 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)
- K112349: Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 5.

## Indications for use
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K153258
Methodology: https://510kreport.com/methodology