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FDA 510(k)

Stone Retrieval Balloon Catheter

K-Number: K210660 · 2021-04-27

ApplicantAnrei Medical (Hangzhou) Co., Ltd.
Decision Date2021-04-27
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stone Retrieval Balloon Catheter is a medical device manufactured by Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-04-27 under approval number K210660. 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 Catheter?

Stone Retrieval Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-04-27. It is manufactured by Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210660.

When was Stone Retrieval Balloon Catheter approved by the FDA?

Stone Retrieval Balloon Catheter received FDA 510(k) clearance on 2021-04-27, under approval number K210660.

What company makes Stone Retrieval Balloon Catheter?

Stone Retrieval Balloon Catheter is manufactured by Anrei Medical (Hangzhou) Co., Ltd..

What is the FDA product code for Stone Retrieval Balloon Catheter?

The FDA product code for Stone Retrieval Balloon Catheter is GCA.

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Other Devices by Anrei Medical (Hangzhou) Co., Ltd.

K201771Single Use Rotatable and Repositionable Hemoclip K192048Single Use Endoscope Valves Set K210917Single Use Injection Needle K202987Rescue Pulmonary Grasping Forceps K212999Multi-Functional Electrosurgical Knife

Related Devices (Code: GCA)

K170292Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. K173659Howell D.A.S.H Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. K173414Advance Biliary Balloon CatheterCook Incorporated K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, 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.

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