# K171637: OpClear System

- Pathway: 510(k) (Traditional)
- Applicant: Cipher Surgical, Ltd.
- Decided: Feb 26, 2018 after 269 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: 4 generations back to K904871 (1991). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045, Minimally Invasive Devices, LLC (2008) Summary page 4.

## Most influential descendants
- K222695: troCarWash™ System (2023), 1 descendant of its own
- K233442: troCarWash™ System (2024), 0 descendants of its own
- K221824: OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 (2022), 0 descendants of its own

## Indications for use
The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.

Source page: https://510kreport.com/device/K171637
Methodology: https://510kreport.com/methodology