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FDA 510(k)

Disposable Stone Extraction basket

K-Number: K201509 · 2020-12-16

Decision Date2020-12-16
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Stone Extraction basket is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-16 under 510(k) 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. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K201509.

When did Disposable Stone Extraction basket receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Stone Extraction basket?

The FDA 510(k) record lists Hangzhou AGS MedTech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hangzhou AGS MedTech Co., Ltd. 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.

View all 19 devices →

Related Devices (Code: LQR)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.