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FDA 510(k)

Histofreezer V

K-Number: K240106 · 2024-06-10

ApplicantCryoconcepts LP
Decision Date2024-06-10
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Histofreezer V is a medical device manufactured by Cryoconcepts LP. It received FDA 510(k) clearance on 2024-06-10 under approval number K240106. 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 Histofreezer V?

Histofreezer V is a medical device that received FDA 510(k) clearance on 2024-06-10. It is manufactured by Cryoconcepts LP. The 510(k) number is K240106.

When was Histofreezer V approved by the FDA?

Histofreezer V received FDA 510(k) clearance on 2024-06-10, under approval number K240106.

What company makes Histofreezer V?

Histofreezer V is manufactured by Cryoconcepts LP.

What is the FDA product code for Histofreezer V?

The FDA product code for Histofreezer V is GEH.

Other Devices by Cryoconcepts LP

K172769CryOmega Flexx K190407CryoLab K183601CryoTouch K211099Freeze’n Clear Skin Clinic Warts & Tags K242625Freeze Point & Private Label Versions K251493Skin Clinic Freeze Point for Warts and Skin Tags

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Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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