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FDA 510(k)

Disposable Stone Extraction basket

K-Number: K201509 · 2020-12-16

ApplicantHangzhou AGS MedTech Co., Ltd.
Decision Date2020-12-16
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Stone Extraction basket is a medical device manufactured by Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-16 under approval number K201509. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Stone Extraction basket?

Disposable Stone Extraction basket is a medical device that received FDA 510(k) clearance on 2020-12-16. It is manufactured by Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K201509.

When was Disposable Stone Extraction basket approved by the FDA?

Disposable Stone Extraction basket received FDA 510(k) clearance on 2020-12-16, under approval number K201509.

What company makes Disposable Stone Extraction basket?

Disposable Stone Extraction basket is manufactured by Hangzhou AGS MedTech Co., Ltd..

What is the FDA product code for Disposable Stone Extraction basket?

The FDA product code for Disposable Stone Extraction basket is LQR.

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Related Devices (Code: LQR)

K173687Strange Bile Duct Stone Exploration SetCook Incorporated K170898Wittich Nitinol Stone BasketCook Incorporated K170811Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. K173009NCompass Nitinol Stone ExtractorsCook Incorporated K182381Wilson-Cook Mini BasketWilson-Cook Medical, Inc. K171969Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction BasketWilson-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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