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FDA 510(k)

Disposable Stone Extraction Basket

K-Number: K253056 · 2026-04-03

ApplicantZhejiang Soudon Medical Technology Co., Ltd.
Decision Date2026-04-03
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 Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253056. 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 2026-04-03. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K253056.

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

Disposable Stone Extraction Basket received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253056.

Who is the listed applicant for Disposable Stone Extraction Basket?

The FDA 510(k) record lists Zhejiang Soudon Medical Technology 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 Zhejiang Soudon Medical Technology 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.

K253013Disposable Stone Retrieval Balloon CatheterK232450Disposable Hemostatic ClipsK232442Disposable Endoscope Injection NeedlesK232476Disposable Sphincterotome

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.

K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover Retrieval BasketBoston Scientific CorporationK201509Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd.

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.

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