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FDA 510(k)

Celsio Flexible Cryocatheter System

K-Number: K240776 · 2024-09-24

ApplicantEndocision Technologies, Inc.
Decision Date2024-09-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Celsio Flexible Cryocatheter System is the device name listed in this FDA 510(k) record. The listed applicant is Endocision Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K240776. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celsio Flexible Cryocatheter System?

Celsio Flexible Cryocatheter System is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Endocision Technologies, Inc.. The 510(k) number is K240776.

When did Celsio Flexible Cryocatheter System receive FDA 510(k) clearance?

Celsio Flexible Cryocatheter System received FDA 510(k) clearance on 2024-09-24, under 510(k) number K240776.

Who is the listed applicant for Celsio Flexible Cryocatheter System?

The FDA 510(k) record lists Endocision Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celsio Flexible Cryocatheter System?

The FDA product code for Celsio Flexible Cryocatheter System is GEH.

Related Devices (Code: GEH)

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.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

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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