Cleared Special

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 (K221824) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221824 · Cipher Surgical Limited · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
57d
Days
Class 2
Risk

K221824 is an FDA 510(k) clearance for the OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), O.... Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Cipher Surgical Limited (Coventry, GB). The FDA issued a Cleared decision on August 19, 2022 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cipher Surgical Limited devices

Submission Details

510(k) Number K221824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2022
Decision Date August 19, 2022
Days to Decision 57 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 46
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K221824.
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · Diversatek Healthcare · Nov 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · Changzhou Endoclean Medical Device Co., Ltd. · Oct 2022
Clean Connecting Tube
K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Sep 2022
Erbe's Tubing/Cap Sets
K221177 · Erbe USA, Inc. · Aug 2022
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
K210618 · Chongqing Jinshan Science & Technology Co., Ltd. · Oct 2021
ENDOtube
K203350 · Nissha Medical Technologies Sas · Sep 2021