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Andorate Suction Valve, Andorate Air/Water Valve

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213095

by Ga Health Company Limited

Identifiers

510(k) Number
K213095 FDA 510(k)
FDA Product Code
ODC 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 Andorate Suction Valve and Air/Water Valve are endoscope channel accessories designed to regulate suction, air, and water flow during gastrointestinal and urological procedures. These valves provide controlled access for instrumentation while ensuring precise manipulation of fluid dynamics within the endoscope channel.

Supplied as single-use components, these valves are intended for use with GI endoscopes and are classified under the OpenFDA device type 'Endoscope Channel Accessory.' They are authorized under FDA 510(k) clearance (K213095) and the EU Medical Device Regulation (MDR). The valves are non-sterile and must be sterilized prior to first use, adhering to standard medical device sterilization protocols.

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: PDF Andorate Endoscope Valves and Tubing_BC_202601_L3, GA Health - Endoscopy Medical Devices | Andorate | GI endoscopy, ANDORATE® Valve Kit (K232118) — FDA 510 (k) | Innolitics, andorate Suction Valve, andorate Air/Water Valve (K213095) — FDA 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ga Health Company Limited

Sources (2)

  • FDA 510(k) K213095 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026