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)

AquaPulse® Irrigation Tubing

K-Number: K223171 · 2022-11-10

ApplicantGa Health Company Limited
Decision Date2022-11-10
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaPulse® Irrigation Tubing is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2022-11-10 under approval number K223171. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AquaPulse® Irrigation Tubing?

AquaPulse® Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Ga Health Company Limited. The 510(k) number is K223171.

When was AquaPulse® Irrigation Tubing approved by the FDA?

AquaPulse® Irrigation Tubing received FDA 510(k) clearance on 2022-11-10, under approval number K223171.

What company makes AquaPulse® Irrigation Tubing?

AquaPulse® Irrigation Tubing is manufactured by Ga Health Company Limited.

What is the FDA product code for AquaPulse® Irrigation Tubing?

The FDA product code for AquaPulse® Irrigation Tubing is OCX.

Other Devices by Ga Health Company Limited

K202560AquaPulse Irrigation Tubing K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve 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

View all 12 devices →

Related Devices (Code: OCX)

K161167Seal Single-Use Biopsy ValveEndochoice, Inc. K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. K182275Seal Single Use Biopsy ValveBoston Scientific Corporation K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.

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.

↑