FDA 510(k)

Copan FecalSwab Collection, Transport and Preservation System

K-Number: K220052 · 2022-12-16

Decision Date2022-12-16

Product CodeJSM

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Copan FecalSwab Collection, Transport and Preservation System is a medical device manufactured by Copan Italia Spa. It received FDA 510(k) clearance on 2022-12-16 under approval number K220052. 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 Copan FecalSwab Collection, Transport and Preservation System?

Copan FecalSwab Collection, Transport and Preservation System is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Copan Italia Spa. The 510(k) number is K220052.

When was Copan FecalSwab Collection, Transport and Preservation System approved by the FDA?

Copan FecalSwab Collection, Transport and Preservation System received FDA 510(k) clearance on 2022-12-16, under approval number K220052.

What company makes Copan FecalSwab Collection, Transport and Preservation System?

Copan FecalSwab Collection, Transport and Preservation System is manufactured by Copan Italia Spa.

What is the FDA product code for Copan FecalSwab Collection, Transport and Preservation System?

The FDA product code for Copan FecalSwab Collection, Transport and Preservation System is JSM.

Related Clinical Trials

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Other Devices by Copan Italia Spa

K180052UriSwab-Urine Collection, Transport and Preservation System K201849eNAT molecular collection and preservation medium K232565UriSponge 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. K220739Disposable Urine Collection TubeZhejiang Gongdong Medical Technology 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.