# K233442: troCarWash™ System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: May 21, 2024 after 216 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 6 generations back to K904871 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222695: troCarWash™ System, Biotex, Inc. (2023) Summary page 4.

## Indications for use
The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

Source page: https://510kreport.com/device/K233442
Methodology: https://510kreport.com/methodology