FDA 510(k)

Disposable Ureteral Guide Sheath

K-Number: K241181 · 2024-08-02

ApplicantDongguan Zsr Biomedical Technology Company Limited

Decision Date2024-08-02

Product CodeFED

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Disposable Ureteral Guide Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241181. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Ureteral Guide Sheath?

Disposable Ureteral Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K241181.

When did Disposable Ureteral Guide Sheath receive FDA 510(k) clearance?

Disposable Ureteral Guide Sheath received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241181.

Who is the listed applicant for Disposable Ureteral Guide Sheath?

The FDA 510(k) record lists Dongguan Zsr Biomedical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Ureteral Guide Sheath?

The FDA product code for Disposable Ureteral Guide Sheath is FED.

Other records listing Dongguan Zsr Biomedical Technology Company Limited 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.

K243155Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)

Related Devices (Code: FED)

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development 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.