Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve

K-Number: K200495 · 2020-06-24

ApplicantGa Health Company Limited
Decision Date2020-06-24
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2020-06-24 under approval number K200495. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is a medical device that received FDA 510(k) clearance on 2020-06-24. It is manufactured by Ga Health Company Limited. The 510(k) number is K200495.

When was Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve approved by the FDA?

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve received FDA 510(k) clearance on 2020-06-24, under approval number K200495.

What company makes Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is manufactured by Ga Health Company Limited.

What is the FDA product code for Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

The FDA product code for Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is ODC.

Other Devices by Ga Health Company Limited

K202560AquaPulse Irrigation Tubing K200481Andorate Biopsy Valve, Andorate Biopsy Irrigator K200479AquaPulse Auxiliary Water Connector K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector K202838Andorate Universal Endoscope Tip Guard K223171AquaPulse® Irrigation Tubing

View all 12 devices →

Related Devices (Code: ODC)

K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. K162142Accessory Irrigation AdapterWilson-Cook Medical, Inc. K181712San Antonio StopcockCook Incorporated K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated K192258Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd. K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑