# 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

- Pathway: 510(k) (Special)
- Applicant: Cipher Surgical Limited
- Decided: Aug 19, 2022 after 57 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 5.

## Indications for use
The OpClear® Platform consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions on the distal window of laparoscopes, such as condensation, blood and other tissue particulates, therefore maintaining a clear image of the surgical site. The OpClear® Platform is indicated for use in abdominal laparoscopy.

Source page: https://510kreport.com/device/K221824
Methodology: https://510kreport.com/methodology