# K222695: troCarWash™ System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Feb 17, 2023 after 164 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: 5 generations back to K904871 (1991). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171637: OpClear System, Cipher Surgical, Ltd. (2018) Summary page 4.
- K190029: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar, Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (2019) Summary page 4.

## Most influential descendants
- K233442: troCarWash™ System (2024), 0 descendants of its own

## 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/K222695
Methodology: https://510kreport.com/methodology