Cleared Traditional

ANDORATE® Valve Kit (K232118) - FDA 510(k) Clearance

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

K232118 · Ga Health Company Limited · Gastroenterology & Urology device
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Oct 2023
Decision
91d
Days
Class 2
Risk

K232118 is an FDA 510(k) clearance for the ANDORATE® Valve Kit. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Ga Health Company Limited (Hong Kong, CN). The FDA issued a Cleared decision on October 16, 2023 after a review of 91 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.

View all Ga Health Company Limited devices

Submission Details

510(k) Number K232118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2023
Decision Date October 16, 2023
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 47
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K232118.
Disposable Endoscope Valves System
K232244 · Changzhou Endoclean Medical Device Co., Ltd. · Nov 2023
Disposable Endoscope Valves Kit
K222499 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Nov 2023
BioShield Biopsy Valve (00711124)
K232951 · Steris · Oct 2023
Disposable Endoscope Valve Sets
K220884 · Sml Med-Tech Solutions Limited · Jan 2023
Pentax Medical Valve Set
K222980 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Nov 2022
Disposable Endoscope Valves System
K221331 · Changzhou Endoclean Medical Device Co., Ltd. · Sep 2022