OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpC…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221824 FDA 510(k)
- FDA Product Code
- OCX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OpClear Platform is an Endoscopic Irrigation/Suction System, designed to maintain clear visual access during endoscopic procedures. It combines a reusable control unit with disposable, sterile accessories to remove obstructions such as blood, debris, or fluid from the field of view, ensuring uninterrupted surgical visibility in gastroenterology and urology applications.
The system comprises a reusable control unit (CS-CU33) paired with single-use disposable procedure kits (e.g., CS-10-00-300, CS-05-30-315) for irrigation and suction. Supplied sterile and intended for single-use, these kits are regulated under FDA 510(k) clearance and EU MDR compliance. The platform operates in clinical settings requiring precise fluid management, with varying kit sizes accommodating different procedural needs.
Frequently asked questions
What types of procedures is the OpClear Platform designed to support and why is clear visual access important in these settings?
The OpClear Platform is designed for use in gastroenterology and urology procedures, where maintaining clear visual access is critical. It helps remove obstructions like blood, debris, or fluid from the surgical field, ensuring uninterrupted visibility during endoscopic interventions. This is particularly important in delicate procedures where precision and real-time visualization are essential for safe and effective outcomes.
Are the disposable procedure kits for the OpClear Platform single-use or reusable, and why does this matter?
The disposable procedure kits (e.g., CS-10-00-300, CS-05-30-315) are intended for single-use only. This design choice reduces the risk of cross-contamination between patients, ensures sterility, and eliminates the need for cleaning and reprocessing, which can be time-consuming and prone to error. Single-use also aligns with infection control best practices in clinical settings.
What sizes or models of disposable kits are available, and how do they differ from one another?
The OpClear Platform offers multiple disposable kit models, including CS-10-00-300, CS-10-30-315, CS-10-00-330, CS-05-00-290, and others, with variations in size (e.g., 290, 300, 315, 330) and potentially different flow rates or suction capabilities. The numerical differences (e.g., 10 vs. 05) may indicate variations in capacity or procedural application, such as higher-volume irrigation for larger procedures or specialized use cases in urology or gastroenterology.
How is the OpClear Control Unit (CS-CU33) paired with the disposable kits, and what role does the footswitch play?
The OpClear Control Unit (CS-CU33) is a reusable device designed to be paired with single-use disposable procedure kits. It provides the core functionality for irrigation and suction during procedures. The included footswitch allows the clinician to operate the system hands-free, improving ergonomics and efficiency by enabling precise control without interrupting the procedure. This is particularly useful in long or complex endoscopic surgeries.
What regulatory pathways have the OpClear Platform and its components followed, and what does this mean for clinicians?
The OpClear Platform, including the reusable control unit and disposable procedure kits, has undergone FDA 510(k) clearance and EU MDR compliance. This means the device has been evaluated for safety and effectiveness according to regulatory standards, ensuring it meets clinical performance requirements. Clinicians can rely on its regulatory approvals as part of their decision-making process when selecting devices for endoscopic procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS ..., PDF K221824 OpClear Platform (CU3 DI3), OpClear Control Unit with ..., The OpClear Platform - Cipher Surgical, OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221824 | Class II | Active |
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Manufacturer
- Manufacturer
- Cipher Surgical Limited
Sources (2)
- FDA 510(k) K221824 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026