Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Single Use Ureteral Access Sheath

K-Number: K220065 · 2022-05-25

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2022-05-25
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220065. 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 Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220065.

When did Single Use Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220065.

Who is the listed applicant for Single Use Ureteral Access Sheath?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Ureteral Access Sheath?

The FDA product code for Single Use Ureteral Access Sheath is FED.

Related Clinical Trials

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.

NCT07377461Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.COMPLETEDNCT07568990Ureteral Access Sheaths in Endoscopic Kidney Stone SurgeryRECRUITINGNCT07655050Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRSRECRUITINGNCT07678255Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative OutcomesNOT_YET_RECRUITINGNCT06547632ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional ApproachTERMINATEDNCT07072598Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URSRECRUITING

Other records listing Zhejiang Chuangxiang 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.

K253132Single use stone retrieval balloonsK251890Disposable Ureteral StentsK230773Endoscopy Irrigation TubingK231471Air/Water Bottle Tubing, CO2 Source TubingK220063Single Use Cytology BrushK212669Single Use Hemoclip

View all 13 devices →

Related Devices (Code: FED)

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.

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

View on FDA Database →

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

↑