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FDA 510(k)

EndoCore

K-Number: K230778 · 2023-09-25

ApplicantPraxis Medical, LLC
Decision Date2023-09-25
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EndoCore is the device name listed in this FDA 510(k) record. The listed applicant is Praxis Medical, LLC. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K230778. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoCore?

EndoCore is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Praxis Medical, LLC. The 510(k) number is K230778.

When did EndoCore receive FDA 510(k) clearance?

EndoCore received FDA 510(k) clearance on 2023-09-25, under 510(k) number K230778.

Who is the listed applicant for EndoCore?

The FDA 510(k) record lists Praxis Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoCore?

The FDA product code for EndoCore is KTI.

Other records listing Praxis Medical, LLC 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.

K200278CytoCore

Related Devices (Code: KTI)

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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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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