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FDA 510(k)

truFreeze System

K-Number: K171626 · 2017-08-30

ApplicantCSA Medical, Inc.
Decision Date2017-08-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

truFreeze System is a medical device manufactured by CSA Medical, Inc.. It received FDA 510(k) clearance on 2017-08-30 under approval number K171626. 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 truFreeze System?

truFreeze System is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by CSA Medical, Inc.. The 510(k) number is K171626.

When was truFreeze System approved by the FDA?

truFreeze System received FDA 510(k) clearance on 2017-08-30, under approval number K171626.

What company makes truFreeze System?

truFreeze System is manufactured by CSA Medical, Inc..

What is the FDA product code for truFreeze System?

The FDA product code for truFreeze System is GEH.

Other Devices by CSA Medical, Inc.

K162695truFreeze System K161557truFreeze System K172041truFreeze System K171522truFreeze Rapid AV Spray Kit K163244truFreeze System K201183Vortex Radial Spray Catheter

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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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