Cleared Traditional

ANDORATE® Valve Kit (K230932) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230932 · Ga Health Company Limited · Gastroenterology & Urology device
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Jul 2023
Decision
95d
Days
Class 2
Risk

K230932 is an FDA 510(k) clearance for the ANDORATE® Valve Kit. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Ga Health Company Limited (Hong Kong, CN). The FDA issued a Cleared decision on July 7, 2023 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K230932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date July 07, 2023
Days to Decision 95 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 130d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K230932.
Air/Water Bottle Tubing, CO2 Source Tubing
K231471 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Sep 2023
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · Medivators · Aug 2023
Protego Air Water Connector
K231602 · Ga Health Company Limited · Aug 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · Saneso, Inc. · Feb 2023
troCarWash™ System
K222695 · Biotex, Inc. · Feb 2023
AquaPulse® Irrigation Tubing
K223171 · Ga Health Company Limited · Nov 2022