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FDA 510(k)

andorate Suction Valve, andorate Air/Water Valve

K-Number: K213095 · 2022-01-12

ApplicantGa Health Company Limited
Decision Date2022-01-12
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

andorate Suction Valve, andorate Air/Water Valve is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2022-01-12 under 510(k) number K213095. 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 Suction Valve, andorate Air/Water Valve?

andorate Suction Valve, andorate Air/Water Valve is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Ga Health Company Limited. The 510(k) number is K213095.

When did andorate Suction Valve, andorate Air/Water Valve receive FDA 510(k) clearance?

andorate Suction Valve, andorate Air/Water Valve received FDA 510(k) clearance on 2022-01-12, under 510(k) number K213095.

Who is the listed applicant for andorate Suction Valve, andorate Air/Water Valve?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ga Health Company Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232118ANDORATE® Valve KitK231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingK230932ANDORATE® Valve KitK230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveK223171AquaPulse® Irrigation TubingK202838Andorate Universal Endoscope Tip Guard

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Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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.

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