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FDA 510(k)

Stone Retrieval Balloon

K-Number: K200173 · 2020-05-01

ApplicantHangzhou AGS MedTech Co., Ltd.
Decision Date2020-05-01
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stone Retrieval Balloon is a medical device manufactured by Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under approval number K200173. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stone Retrieval Balloon?

Stone Retrieval Balloon is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K200173.

When was Stone Retrieval Balloon approved by the FDA?

Stone Retrieval Balloon received FDA 510(k) clearance on 2020-05-01, under approval number K200173.

What company makes Stone Retrieval Balloon?

Stone Retrieval Balloon is manufactured by Hangzhou AGS MedTech Co., Ltd..

What is the FDA product code for Stone Retrieval Balloon?

The FDA product code for Stone Retrieval Balloon is GCA.

Related Clinical Trials

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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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