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FDA 510(k)

UriSponge™

K-Number: K232565 · 2024-10-11

ApplicantCopan Italia Spa
Decision Date2024-10-11
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UriSponge™ is the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K232565. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UriSponge™?

UriSponge™ is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Copan Italia Spa. The 510(k) number is K232565.

When did UriSponge™ receive FDA 510(k) clearance?

UriSponge™ received FDA 510(k) clearance on 2024-10-11, under 510(k) number K232565.

Who is the listed applicant for UriSponge™?

The FDA 510(k) record lists Copan Italia Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UriSponge™?

The FDA product code for UriSponge™ is JSM.

Other records listing Copan Italia Spa 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.

K232357Copan Universal Transport Medium (UTM-RT) SystemK220052Copan FecalSwab Collection, Transport and Preservation SystemK201849eNAT molecular collection and preservation mediumK180052UriSwab-Urine Collection, Transport and Preservation System

Related Devices (Code: JSM)

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.

K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.K220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.K233534Viral Transport MediumHardy Diagnostics

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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