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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 a medical device manufactured by Endocision Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-24 under approval 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. It is manufactured by Endocision Technologies, Inc.. The 510(k) number is K240776.

When was Celsio Flexible Cryocatheter System approved by the FDA?

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

What company makes Celsio Flexible Cryocatheter System?

Celsio Flexible Cryocatheter System is manufactured by Endocision Technologies, Inc..

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

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

Related Clinical Trials

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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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