FDA 510(k)

UriSponge

K-Number: K232565 · 2024-10-11

Decision Date2024-10-11

Product CodeJSM

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

UriSponge is a medical device manufactured by Copan Italia Spa. It received FDA 510(k) clearance on 2024-10-11 under approval 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. It is manufactured by Copan Italia Spa. The 510(k) number is K232565.

When was UriSponge approved by the FDA?

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

What company makes UriSponge?

UriSponge is manufactured by Copan Italia Spa.

What is the FDA product code for UriSponge?

The FDA product code for UriSponge is JSM.

Other Devices by Copan Italia Spa

K180052UriSwab-Urine Collection, Transport and Preservation System K201849eNAT molecular collection and preservation medium K220052Copan FecalSwab Collection, Transport and Preservation System K232357Copan Universal Transport Medium (UTM-RT) System

Related Devices (Code: JSM)

K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. K180052UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa

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.